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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95947

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 08, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cardinal Health 200, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 12

Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ10; 8) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ11; 9) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ12; 10) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ13; 11) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ14; 12) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ15; 13) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ16; 14) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ17; 15) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ18; 16) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ19; 17) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ20; 18) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU1; 19) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU2; 20) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU3; 21) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU4; 22) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU5; 23) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU6; 24) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU7; 25) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU8; 26) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU9; 27) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUA; 28) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUB; 29) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUC; 30) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUD; 31) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUE; 32) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUF; 33) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU2; 34) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU3; 35) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU4; 36) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU5; 37) KIT, HEAD AND NECK , Catalog Number:PG40HNAJUC; 38) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ10; 39) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ11; 40) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ12; 41) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ13; 42) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ14; 43) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ15; 44) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ16; 45) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ17; 46) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ18; 47) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ19; 48) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ20; 49) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ21; 50) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ22; 51) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ23; 52) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ24; 53) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU4; 54) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU5; 55) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU6; 56) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU7; 57) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU8; 58) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU9; 59) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUE; 60) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUF; 61) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME1; 62) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME2; 63) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME3; 64) KIT, WILLIAMS SPINE , Cat

Z-1126-2025
Recall number
Z-1126-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) PB23DFCM3, UDI-DI:10888439587050 (each) 50888439587058 (case), Lot Number: J37U13 ; 2) PB23DFCM4, UDI-DI:10888439601053 (each) 50888439601051 (case), Lot Number: J37U14 ; 3) PB23DFCM5, UDI-DI:10888439641790 (each) 50888439641798 (case), Lot Number: J46C08 ; 4) PB23DFCM6, UDI-DI:10888439836172 (each) 50888439836170 (case), Lot Number: J6050A ; 5) PB23DFCM7, UDI-DI:10888439853087 (each) 50888439853085 (case), Lot Number: J7704J ; 6) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J4952P ; 7) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J53W77 ; 8) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J5679N ; 9) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J84K06 ; 10) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J85W31 ; 11) PE40HNAJ10, UDI-DI:10195594746513 (each) 50195594746511 (case), Lot Number: 5918338 ; 12) PE40HNAJ11, UDI-DI:10195594777685 (each) 50195594777683 (case), Lot Number: 6279857 ; 13) PE40HNAJ12, UDI-DI:10195594808051 (each) 50195594808059 (case), Lot Number: 5649225 ; 14) PE40HNAJ13, UDI-DI:10195594878672 (each) 50195594878670 (case), Lot Number: 6279859 ; 15) PE40HNAJ14, UDI-DI:10197106057902 (each) 50197106057900 (case), Lot Number: 6487892 ; 16) PE40HNAJ15, UDI-DI:10197106116449 (each) 50197106116447 (case), Lot Number: 6487896 ; 17) PE40HNAJ16, UDI-DI:10197106138632 (each) 50197106138630 (case), Lot Number: 5 ; 18) PE40HNAJ16, UDI-DI:10197106138632 (each) 50197106138630 (case), Lot Number: 6560940 ; 19) PE40HNAJ17, UDI-DI:10197106224205 (each) 50197106224203 (case), Lot Number: 6568677 ; 20) PE40HNAJ18, UDI-DI:10197106480168 (each) 50197106480166 (case), Lot Number: 7197963 ; 21) PE40HNAJ19, UDI-DI:10197106571453 (each) 50197106571451 (case), Lot Number: 7280098 ; 22) PE40HNAJ20, UDI-DI:10197106587300 (each) 50197106587308 (case), Lot Number: 7287558 ; 23) PE40HNAJU1, UDI-DI:10195594142469 (each) 50195594142467 (case), Lot Number: J9602A ; 24) PE40HNAJU2, UDI-DI:10195594240776 (each) 50195594240774 (case), Lot Number: J9699U ; 25) PE40HNAJU3, UDI-DI:10195594358556 (each) 50195594358554 (case), Lot Number: 5324049 ; 26) PE40HNAJU4, UDI-DI:10195594448806 (each) 50195594448804 (case), Lot Number: 5533323 ; 27) PE40HNAJU5, UDI-DI:10195594541224 (each) 50195594541222 (case), Lot Number: 5565994 ; 28) PE40HNAJU6, UDI-DI:10195594585716 (each) 50195594585714 (case), Lot Number: 5664093 ; 29) PE40HNAJU7, UDI-DI:10195594629632 (each) 50195594629630 (case), Lot Number: 5775805 ; 30) PE40HNAJU8, UDI-DI:10195594666194 (each) 50195594666192 (case), Lot Number: 5918339 ; 31) PE40HNAJU9, UDI-DI:10195594700324 (each) 50195594700322 (case), Lot Number: 6022074 ; 32) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: J8393H ; 33) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 5858463 ; 34) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6702004 ; 35) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6702005 ; 36) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6909986 ; 37) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6416698 ; 38) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6987101 ; 39) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 7287561 ; 40) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 7280096 ; 41) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: J7905A ; 42) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: J8064N ; 43) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 5631065 ; 44) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6279860 ; 45) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 5858463 ; 46) PE40HNAJUB, UDI-DI:10197106566732 (each) 50197106566730 (case), Lot Number: 7280096 ; 47) PE40HNAJUC, UDI-DI:10197106630389 (each) 50197106630387 (case), Lot Number: 7287559 ; 48) PE40HNAJUC, UDI-DI:10197106630389 (each) 50197106630387 (case), Lot Number: 7331327 ; 49) PE40HNAJUD, UDI-DI:10197106663776 (each) 50197106663774 (case), Lot Number: 7332883 ; 50) PE40HNAJUE, UDI-DI:10197106692929 (each) 50197106692927 (case), Lot Number: 7332890 ; 51) PE40HNAJUE, UDI-DI:10197106692929 (each) 50197106692927 (case), Lot Number: 7287559 ; 52) PE40HNAJUF, UDI-DI:10197106755235 (each) 50197106755233 (case), Lot Number: 7332892 ; 53) PE40HNAJUF, UDI-DI:10197106755235 (each) 50197106755233 (case), Lot Number: 6779831 ; 54) PG40HNAJU2, UDI-DI:10888439568592 (each) 50888439568590 (case), Lot Number: J37U04 ; 55) PG40HNAJU3, UDI-DI:10888439786200 (each) 50888439786208 (case), Lot Number: J5678G ; 56) PG40HNAJU3, UDI-DI:10888439786200 (each) 50888439786208 (case), Lot Number: J5678J ; 57) PG40HNAJU3, UDI-DI:10888439786200 (each) 50888439786208 (case), Lot Number: J6278K ; 58) PG40HNAJU4, UDI-DI:10888439879537 (each) 50888439879535 (case), Lot Number: J7904Z ; 59) PG40HNAJU5, UDI-DI:10888439903829 (each) 50888439903827 (case), Lot Number: J7904Z ; 60) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J37U05 ; 61) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J4219Y ; 62) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J4219Z ; 63) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J46A94 ; 64) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J46A95 ; 65) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J4951Y ; 66) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J7498X ; 67) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J8393H ; 68) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J8393K ; 69) PG40HNJ10, UDI-DI:10195594042929 (each) 50195594042927 (case), Lot Number: J9602A ; 70) PG40HNJ11, UDI-DI:10195594116903 (each) 50195594116901 (case), Lot Number: 5140303 ; 71) PG40HNJ12, UDI-DI:10195594252014 (each) 50195594252012 (case), Lot Number: 5140306 ; 72) PG40HNJ13, UDI-DI:10195594298098 (each) 50195594298096 (case), Lot Number: 5140335 ; 73) PG40HNJ14, UDI-DI:10195594401672 (each) 50195594401670 (case), Lot Number: 5478801 ; 74) PG40HNJ15, UDI-DI:10195594471101 (each) 50195594471109 (case), Lot Number: 5565993 ; 75) PG40HNJ16, UDI-DI:10195594531249 (each) 50195594531247 (case), Lot Number: J97W47 ; 76) PG40HNJ17, UDI-DI:10195594561390 (each) 50195594561398 (case), Lot Number: 5664091 ; 77) PG40HNJ18, UDI-DI:10195594631321 (each) 50195594631329 (case), Lot Number: 5140301 ; 78) PG40HNJ19, UDI-DI:10195594700232 (each) 50195594700230 (case), Lot Number: 6022074 ; 79) PG40HNJ20, UDI-DI:10195594773083 (each) 50195594773081 (case), Lot Number: 6025778 ; 80) PG40HNJ21, UDI-DI:10195594791742 (each) 50195594791740 (case), Lot Number: 6279857 ; 81) PG40HNJ22, UDI-DI:10195594834920 (each) 50195594834928 (case), Lot Number: 6025781 ; 82) PG40HNJ23, UDI-DI:10195594867980 (each) 50195594867988 (case), Lot Number: 6416697 ; 83) PG40HNJ24, UDI-DI:10197106013274 (each) 50197106013272 (case), Lot Number: 5970332 ; 84) PG40HNJU4, UDI-DI:10888439567311 (each) 50888439567319 (case), Lot Number: J37U04 ; 85) PG40HNJU5, UDI-DI:10888439616682 (each) 50888439616680 (case), Lot Number: J4219Z ; 86) PG40HNJU6, UDI-DI:10888439689907 (each) 50888439689905 (case), Lot Number: J5678H ; 87) PG40HNJU7, UDI-DI:10888439786446 (each) 50888439786444 (case), Lot Number: J4951Y ; 88) PG40HNJU8, UDI-DI:10888439854329 (each) 50888439854327 (case), Lot Number: J79H50 ; 89) PG40HNJU9, UDI-DI:10888439963571 (each) 50888439963579 (case), Lot Number: J8393H ; 90) PG40HNJUE, UDI-DI:10888439342833 (each) 50888439342831 (case), Lot Number: J46A95 ; 91) PG40HNJUE, UDI-DI:10888439342833 (each) 50888439342831 (case), Lot Number: J6366T ; 92) PG40HNJUE, UDI-DI:10888439342833 (each) 50888439342831 (case), Lot Number: J7904Z ; 93) PG40HNJUF, UDI-DI:10888439948400 (each) 50888439948408 (case), Lot Number: J6278P ; 94) PG40HNJUF, UDI-DI:10888439948400 (each) 50888439948408 (case), Lot Number: J7905A ; 95) PN23WGME1, UDI-DI:10197106553213 (each) 50197106553211 (case), Lot Number: 7055825 ; 96) PN23WGME1, UDI-DI:10197106553213 (each) 50197106553211 (case), Lot Number: 7280093 ; 97) PN23WGME2, UDI-DI:10197106594155 (each) 50197106594153 (case), Lot Number: 7280048 ; 98) PN23WGME2, UDI-DI:10197106594155 (each) 50197106594153 (case), Lot Number: 7280091 ; 99) PN23WGME3, UDI-DI:10197106735046 (each) 50197106735044 (case), Lot Number: 7332831 ; 100) PN23WGME3, UDI-DI:10197106735046 (each) 50197106735044 (case), Lot Number: 7349672 ; 101) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7055826 ; 102) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7280092 ; 103) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7280055 ; 104) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7287533 ; 105) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7280061 ; 106) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7287534 ; 107) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7287466 ; 108) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331338 ; 109) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7287483 ; 110) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331319 ; 111) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331284 ; 112) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331323 ; 113) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331456 ; 114) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331313 ; 115) PN23WGMEC, UDI-DI:10197106770887 (each) 50197106770885 (case), Lot Number: 7280043 ; 116) PN23WGMEC, UDI-DI:10197106770887 (each) 50197106770885 (case), Lot Number: 7331320 ; 117) PN43SPUN1, UDI-DI:10197106570739 (each) 50197106570737 (case), Lot Number: 7287491 ; 118) PN43SPUN2, UDI-DI:10197106592663 (each) 50197106592661 (case), Lot Number: 7163141 ; 119) PN43SPUN3, UDI-DI:10197106647974 (each) 50197106647972 (case), Lot Number: 7331296 ; 120) PN43SPUNA, UDI-DI:10197106200025 (each) 50197106200023 (case), Lot Number: 6116185 ; 121) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 6701984 ; 122) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 7331296 ; 123) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 7331430 ; 124) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 7331430 ; 125) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 7332848 ; 126) PN4EACWIA, UDI-DI:10197106335192 (each) 50197106335190 (case), Lot Number: 7122012 ; 127) PN4EACWIA, UDI-DI:10197106335192 (each) 50197106335190 (case), Lot Number: 7160478 ; 128) PN4EACWIA, UDI-DI:10197106335192 (each) 50197106335190 (case), Lot Number: 7260071 ; 129) PN4EACWIB, UDI-DI:10197106525913 (each) 50197106525911 (case), Lot Number: 6560923 ; 130) PW40HNJU1, UDI-DI:10197106158913 (each) 50197106158911 (case), Lot Number: 6560940 ; 131) PW40HNJU2, UDI-DI:10197106226179 (each) 50197106226177 (case), Lot Number: 5 ; 132) PW40HNJU2, UDI-DI:10197106226179 (each) 50197106226177 (case), Lot Number: 6568677 ; 133) PW40HNJU3, UDI-DI:10197106304631 (each) 50197106304639 (case), Lot Number: 6702004 ; 134) PW40HNJU4, UDI-DI:10197106386293 (each) 50197106386291 (case), Lot Number: 6717949 ; 135) PW40HNJU5, UDI-DI:10197106454565 (each) 50197106454563 (case), Lot Number: 6779831 ; 136) PW40HNJU6, UDI-DI:10197106496633 (each) 50197106496631 (case), Lot Number: 6909988 ; 137) PW40HNJU7, UDI-DI:10197106579978 (each) 50197106579976 (case), Lot Number: 7280095 ; 138) PW40HNJUA, UDI-DI:10197106014189 (each) 50197106014187 (case), Lot Number: 7280097 ; 139) PW40HNJUA, UDI-DI:10197106014189 (each) 50197106014187 (case), Lot Number: 7331340 ; 140) PW40HNJUB, UDI-DI:10197106630341 (each) 50197106630349 (case), Lot Number: 7331327 ; 141) PW40HNJUC, UDI-DI:10197106663745 (each) 50197106663743 (case), Lot Number: 7332886 ; 142) PW40HNJUD, UDI-DI:10197106692875 (each) 50197106692873 (case), Lot Number: 7332883 ; 143) PW40HNJUE, UDI-DI:10197106758601 (each) 50197106758609 (case), Lot Number: 7332892 ; 144) SBA30MFOCA, UDI-DI:10195594120450 (each) 50195594120458 (case), Lot Number: J9699T ; 145) SBA30MFOCA, UDI-DI:10195594120450 (each) 50195594120458 (case), Lot Number: 5324049 ; 146) SBA30MFOCB, UDI-DI:10195594378011 (each) 50195594378019 (case), Lot Number: 5405624 ; 147) SBA30MFOCB, UDI-DI:10195594378011 (each) 50195594378019 (case), Lot Number: 5508057 ; 148) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5858463 ; 149) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 6560942 ; 150) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5565993 ; 151) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: J97W47 ; 152) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5664093 ; 153) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5664091 ; 154) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5664094 ; 155) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 6022075 ; 156) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 6416700 ; 157) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 6487896 ; 158) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 6717950 ; 159) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 6717949 ; 160) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 7280095 ; 161) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 7332887 ; 162) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 7332883 ; 163) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 7332888 ; 164) SBA30PEMD1, UDI-DI:10195594762902 (each) 50195594762900 (case), Lot Number: 6133661 ; 165) SBA38FTVAC, UDI-DI:10888439938210 (each) 50888439938218 (case), Lot Number: J6786C ; 166) SBA38FTVAD, UDI-DI:10195594972226 (each) 50195594972224 (case), Lot Number: 6701941 ; 167) SBA38FTVAD, UDI-DI:10195594972226 (each) 50195594972224 (case), Lot Number: 6701940 ; 168) SBA38FTVAD, UDI-DI:10195594972226 (each) 50195594972224 (case), Lot Number: 5664019 ; 169) SBA38FTVAD, UDI-DI:10195594972226 (each) 50195594972224 (case), Lot Number: 5891283 ; 170) SBA38FTVAE, UDI-DI:10197106422212 (each) 50197106422210 (case), Lot Number: 7122097 ; 171) SBA38FTVAE, UDI-DI:10197106422212 (each) 50197106422210 (case), Lot Number: 6485588 ; 172) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7360139 ; 173) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7280055 ; 174) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6701938 ; 175) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7005442 ; 176) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6701970 ; 177) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7260067 ; 178) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7287457 ; 179) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7332803 ; 180) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: J4218Z ; 181) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7332814 ; 182) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: J4680J ; 183) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: J4950U ; 184) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: J6277R ; 185) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 5775788 ; 186) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 5891293 ; 187) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6022056 ; 188) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6264448 ; 189) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6345500 ; 190) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6485576 ; 191) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6683719 ; 192) SBA40FPJUB, UDI-DI:10197106722121 (each) 50197106722129 (case), Lot Number: 6779832 ; 193) SBA40FPJUB, UDI-DI:10197106722121 (each) 50197106722129 (case), Lot Number: 7332890 ; 194) SBA43BSUNA, UDI-DI:10197106212455 (each) 50197106212453 (case), Lot Number: 6485593 ; 195) SBA4JDFCB1, UDI-DI:10197106730447 (each) 50197106730445 (case), Lot Number: 7349697 ; 196) SBA4JDFCBA, UDI-DI:10197106527900 (each) 50197106527908 (case), Lot Number: 7320242 ; 197) SBA4JDFCBC, UDI-DI:10197106654477 (each) 50197106654475 (case), Lot Number: 7320243 ; 198) SBA4JFDCM1, UDI-DI:10197106731321 (each) 50197106731329 (case), Lot Number: 7349697 ; 199) SBA4JFDCMA, UDI-DI:10197106518977 (each) 50197106518975 (case), Lot Number: 7320241 ; 200) SBA51FFK10, UDI-DI:10195594738402 (each) 50195594738400 (case), Lot Number: 6232004 ; 201) SBA51FFK11, UDI-DI:10195594890940 (each) 50195594890948 (case), Lot Number: 6364783 ; 202) SBA51FFK12, UDI-DI:10197106025451 (each) 50197106025459 (case), Lot Number: 6416684 ; 203) SBA51FFK13, UDI-DI:10197106192658 (each) 50197106192656 (case), Lot Number: 6416685 ; 204) SBA51FFK14, UDI-DI:10197106252178 (each) 50197106252176 (case), Lot Number: 6748352 ; 205) SBA51FFK15, UDI-DI:10197106298336 (each) 50197106298334 (case), Lot Number: 6470287 ; 206) SBA51FFK16, UDI-DI:10197106367636 (each) 50197106367634 (case), Lot Number: 6928777 ; 207) SBA51FFK17, UDI-DI:10197106512166 (each) 50197106512164 (case), Lot Number: 7280089 ; 208) SBA51FFK18, UDI-DI:10197106553718 (each) 50197106553716 (case), Lot Number: 7280093 ; 209) SBA51FFK19, UDI-DI:10197106593585 (each) 50197106593583 (case), Lot Number: 7280090 ; 210) SBA51FFK20, UDI-DI:10197106661352 (each) 50197106661350 (case), Lot Number: 7332856 ; 211) SBA51FFK21, UDI-DI:10197106753675 (each) 50197106753673 (case), Lot Number: 7349671 ; 212) SBA51FFK22, UDI-DI:10197106779521 (each) 50197106779529 (case), Lot Number: 7332878 ; 213) SBA51FFKC3, UDI-DI:10888439755107 (each) 50888439755105 (case), Lot Number: J6278G ; 214) SBA51FFKC4, UDI-DI:10888439773248 (each) 50888439773246 (case), Lot Number: J6278J ; 215) SBA51FFKC5, UDI-DI:10195594967352 (each) 50195594967350 (case), Lot Number: J9602H ; 216) SBA51FFKC6, UDI-DI:10195594067557 (each) 50195594067555 (case), Lot Number: 20M067262 ; 217) SBA51FFKC6, UDI-DI:10195594067557 (each) 50195594067555 (case), Lot Number: 5135994 ; 218) SBA51FFKC7, UDI-DI:10195594167332 (each) 50195594167330 (case), Lot Number: 5138327 ; 219) SBA51FFKC8, UDI-DI:10195594310912 (each) 50195594310910 (case), Lot Number: 5405617 ; 220) SBA51FFKC9, UDI-DI:10195594700027 (each) 50195594700025 (case), Lot Number: 6022070 ; 221) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J37T95 ; 222) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J43U72 ; 223) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J46A82 ; 224) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J74A02 ; 225) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J4951U ; 226) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J8064R ; 227) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J86N66 ; 228) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J70X09 ; 229) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J70X08 ; 230) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5533310 ; 231) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5631062 ; 232) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5405618 ; 233) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5508052 ; 234) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5508054 ; 235) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5664049 ; 236) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5533321 ; 237) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 6470285 ; 238) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 6470287 ; 239) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 6563975 ; 240) SBA51FFKCF, UDI-DI:10197106344910 (each) 50197106344918 (case), Lot Number: 7005466 ; 241) SBA51MFKO1, UDI-DI:10197106800713 (each) 50197106800711 (case), Lot Number: 7331351 ; 242) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 6779960 ; 243) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 6788670 ; 244) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7160529 ; 245) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7163105 ; 246) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7266055 ; 247) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7160538 ; 248) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7160538 ; 249) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7280116 ; 250) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7320241 ; 251) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7280112 ; 252) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7332922 ; 253) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7332921 ; 254) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7349698 ; 255) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7349699 ; 256) SBA51PMKO9, UDI-DI:10197106490426 (each) 50197106490424 (case), Lot Number: 7265984 ; 257) SBA51PMKOE, UDI-DI:10197106223901 (each) 50197106223909 (case), Lot Number: 6775048 ; 258) SBA51PMKOF, UDI-DI:10197106527207 (each) 50197106527205 (case), Lot Number: 7332874 ; 259) SBA51PMKOF, UDI-DI:10197106527207 (each) 50197106527205 (case), Lot Number: 7280090 ; 260) SBA51PMKOF, UDI-DI:10197106527207 (each) 50197106527205 (case), Lot Number: 7287539 ; 261) SBA51PMKOF, UDI-DI:10197106527207 (each) 50197106527205 (case), Lot Number: 7332861 ; 262) SBA5FDLMM2, UDI-DI:10195594883492 (each) 50195594883490 (case), Lot Number: 5530913 ; 263) SBA5FDLMM3, UDI-DI:10197106248997 (each) 50197106248995 (case), Lot Number: 6907763 ; 264) SBA5FDLMMB, UDI-DI:10885425502578 (each) 50885425502576 (case), Lot Number: J4218Z ; 265) SBA5FDLMMB, UDI-DI:10885425502578 (each) 50885425502576 (case), Lot Number: J4950Y ; 266) SBA5FDLMMB, UDI-DI:10885425502578 (each) 50885425502576 (case), Lot Number: J4680A ; 267) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7280059 ; 268) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7055832 ; 269) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7331287 ; 270) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6560923 ; 271) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7331457 ; 272) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7332845 ; 273) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J7609N ; 274) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J7904N ; 275) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J8123N ; 276) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J8692M ; 277) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J96N39 ; 278) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J9602N ; 279) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5311244 ; 280) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5138168 ; 281) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5631042 ; 282) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5664033 ; 283) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5891282 ; 284) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6025767 ; 285) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6345502 ; 286) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6560930 ; 287) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6683719 ; 288) SBA69FFC18, UDI-DI:10888439587111 (each) 50888439587119 (case), Lot Number: J3593N ; 289) SBA69FFC19, UDI-DI:10888439650921 (each) 50888439650929 (case), Lot Number: J46C07 ; 290) SBA69FFC20, UDI-DI:10888439668124 (each) 50888439668122 (case), Lot Number: J4952N ; 291) SBA69FFC21, UDI-DI:10888439738261 (each) 50888439738269 (case), Lot Number: J53W77 ; 292) SBA69FFC22, UDI-DI:10888439852011 (each) 50888439852019 (case), Lot Number: J7704J ; 293) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J37U13 ; 294) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J53W78 ; 295) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J43U79 ; 296) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J7963U ; 297) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J7963U ; 298) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J85W32 ; 299) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J6278W ; 300) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J6368X ; 301) SBA69FFKW2, UDI-DI:10195594163426 (each) 50195594163424 (case), Lot Number: J9850H ; 302) SBA69FFKW3, UDI-DI:10195594381714 (each) 50195594381712 (case), Lot Number: 5508060 ; 303) SBA69FFKW4, UDI-DI:10195594717445 (each) 50195594717443 (case), Lot Number: 5970335 ; 304) SBA69FFKW5, UDI-DI:10197106209110 (each) 50197106209118 (case), Lot Number: 6701854 ; 305) SBA69FFKW6, UDI-DI:10197106395783 (each) 50197106395781 (case), Lot Number: 7160529 ; 306) SBA69FFKW7, UDI-DI:10197106716670 (each) 50197106716678 (case), Lot Number: 7332924 ; 307) SBA69FFKWM, UDI-DI:10888439589658 (each) 50888439589656 (case), Lot Number: J4952N ; 308) SBA69FFKWM, UDI-DI:10888439589658 (each) 50888439589656 (case), Lot Number: J5679N ; 309) SBA69FFKWM, UDI-DI:10888439589658 (each) 50888439589656 (case), Lot Number: J8693M ; 310) SBA69FFKWM, UDI-DI:10888439589658 (each) 50888439589656 (case), Lot Number: 5664108 ; 311) SBA69FFKWN, UDI-DI:10195594529284 (each) 50195594529282 (case), Lot Number: 6788668 ; 312) SBA69FFKWN, UDI-DI:10195594529284 (each) 50195594529282 (case), Lot Number: 6133662 ; 313) SBA69FFKWP, UDI-DI:10197106563731 (each) 50197106563739 (case), Lot Number: 7332920 ; 314) SBA69MFSU1, UDI-DI:10195594057909 (each) 50195594057907 (case), Lot Number: J9602W ; 315) SBA69MFSU2, UDI-DI:10195594353841 (each) 50195594353849 (case), Lot Number: 5140385 ; 316) SBA69MFSU3, UDI-DI:10195594448370 (each) 50195594448378 (case), Lot Number: 5533341 ; 317) SBA69MFSU4, UDI-DI:10197106058350 (each) 50197106058358 (case), Lot Number: 6560947 ; 318) SBA69MFSU5, UDI-DI:10197106104736 (each) 50197106104734 (case), Lot Number: 6560948 ; 319) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6788668 ; 320) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6788669 ; 321) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6779959 ; 322) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7005491 ; 323) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7163105 ; 324) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7163105 ; 325) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7266056 ; 326) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7269982 ; 327) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7280113 ; 328) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7280115

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 2 of 12

Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;

Z-1127-2025
Recall number
Z-1127-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J8241D ; 2) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J79Z55 ; 3) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220A ; 4) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220D ; 5) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J4953F ; 6) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J46C13 ;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 3 of 12

Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC

Z-1128-2025
Recall number
Z-1128-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7266123 ; 2) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7331357 ; 3) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7266123 ; 4) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333452 ; 5) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333453 ; 6) SOT4FRUWFC, UDI-DI:10197106732304 (each) 50197106732302 (case), Lot Number: 7350031 ;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 4 of 12

Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U 6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X 7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y 8) SLH AAA PACK, Catalog Number:SCV13AASLA 9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10 10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4 11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5 12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6 13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7 14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8 15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9 16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP 17) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHQ 18) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHR 19) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHS 20) NEURO EMBOLISM PACK, Catalog Number:SNE11AN102 21) NEURO EMBOLISM PACK, Catalog Number:SNE11AN10E

Z-1129-2025
Recall number
Z-1129-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 6788690 ; 2) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 6806122 ; 3) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 7160517 ; 4) PVV20110D, UDI-DI:10197106546505 (each) 50197106546503 (case), Lot Number: 7287574 ; 5) PVV2CA103, UDI-DI:10888439714081 (each) 50888439714089 (case), Lot Number: J46C12 ; 6) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J46C11 ; 7) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J43W16 ; 8) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J6022K ; 9) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J7708R ; 10) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J79Z50 ; 11) PVV2CA10U, UDI-DI:10888439693607 (each) 50888439693605 (case), Lot Number: J8241D ; 12) PVV2CA10U, UDI-DI:10888439693607 (each) 50888439693605 (case), Lot Number: J84K11 ; 13) PVV2CA10X, UDI-DI:10888439967265 (each) 50888439967263 (case), Lot Number: J8998R ; 14) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5140389 ; 15) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5664115 ; 16) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5858468 ; 17) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5858469 ; 18) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 6116189 ; 19) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 6251075 ; 20) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7055826 ; 21) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7287469 ; 22) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7331456 ; 23) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7332825 ; 24) SCV30VAF10, UDI-DI:10197106231142 (each) 50197106231140 (case), Lot Number: 6702001 ; 25) SCV30VAFH4, UDI-DI:10195594091989 (each) 50195594091987 (case), Lot Number: J8045P ; 26) SCV30VAFH5, UDI-DI:10195594154073 (each) 50195594154071 (case), Lot Number: 5138326 ; 27) SCV30VAFH6, UDI-DI:10195594243616 (each) 50195594243614 (case), Lot Number: J9699Y ; 28) SCV30VAFH7, UDI-DI:10195594324940 (each) 50195594324948 (case), Lot Number: 5405620 ; 29) SCV30VAFH8, UDI-DI:10195594381400 (each) 50195594381408 (case), Lot Number: 5138335 ; 30) SCV30VAFH9, UDI-DI:10195594616182 (each) 50195594616180 (case), Lot Number: D212939 ; 31) SCV30VAFH9, UDI-DI:10195594616182 (each) 50195594616180 (case), Lot Number: 5775803 ; 32) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J3986T ; 33) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J4219R ; 34) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J4877C ; 35) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J6278H ; 36) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J6786K ; 37) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J76N07 ; 38) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J86N63 ; 39) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J86N65 ; 40) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J70X09 ; 41) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J9424P ; 42) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7332861 ; 43) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6701998 ; 44) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6748352 ; 45) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6748352 ; 46) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6470289 ; 47) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6775068 ; 48) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6775065 ; 49) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7005466 ; 50) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7280092 ; 51) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7280093 ; 52) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7005463 ; 53) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7332855 ; 54) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6022069 ; 55) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6133658 ; 56) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6232003 ; 57) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6345513 ; 58) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6416679 ; 59) SNE11AN102, UDI-DI:10197106232293 (each) 50197106232291 (case), Lot Number: 6568688 ; 60) SNE11AN10E, UDI-DI:10197106067062 (each) 50197106067060 (case), Lot Number: 6560950 ;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 5 of 12

Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF108 6) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF109 7) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10V 8) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10W 9) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Y 10) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Z 11) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF111 12) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF112 13) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCP2 14) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP3 15) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP4 16) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPA 17) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPB 18) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPC 19) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPD 20) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPE 21) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPF

Z-1130-2025
Recall number
Z-1130-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) PWV2MF104, UDI-DI:10888439676167 (each) 50888439676165 (case), Lot Number: J46C10 ; 2) PWV2MF105, UDI-DI:10195594004217 (each) 50195594004215 (case), Lot Number: J8998R ; 3) PWV2MF106, UDI-DI:10195594095994 (each) 50195594095992 (case), Lot Number: 5136000 ; 4) PWV2MF107, UDI-DI:10195594148065 (each) 50195594148063 (case), Lot Number: 5140389 ; 5) PWV2MF108, UDI-DI:10195594228941 (each) 50195594228949 (case), Lot Number: 5140389 ; 6) PWV2MF109, UDI-DI:10195594394875 (each) 50195594394873 (case), Lot Number: J65K18 ; 7) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: HP1027 ; 8) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4220A ; 9) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J43W15 ; 10) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4953C ; 11) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6022K ; 12) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6372Z ; 13) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J7708T ; 14) PWV2MF10W, UDI-DI:10888439693645 (each) 50888439693643 (case), Lot Number: J8241D ; 15) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K11 ; 16) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K10 ; 17) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: J65K19 ; 18) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 5775812 ; 19) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 6116189 ; 20) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: 6251076 ; 21) PWV2MF111, UDI-DI:10195594634957 (each) 50195594634955 (case), Lot Number: 5858469 ; 22) PWV2MF112, UDI-DI:10195594711177 (each) 50195594711175 (case), Lot Number: 6022146 ; 23) PWV2MFCP2, UDI-DI:10197106368718 (each) 50197106368716 (case), Lot Number: 6788690 ; 24) PWV2MFCP3, UDI-DI:10197106738399 (each) 50197106738397 (case), Lot Number: 7333448 ; 25) PWV2MFCP4, UDI-DI:10197106784167 (each) 50197106784165 (case), Lot Number: 7360541 ; 26) PWV2MFCPA, UDI-DI:10197106143469 (each) 50197106143467 (case), Lot Number: 6701855 ; 27) PWV2MFCPB, UDI-DI:10197106245491 (each) 50197106245499 (case), Lot Number: 6702040 ; 28) PWV2MFCPB, UDI-DI:10197106245491 (each) 50197106245499 (case), Lot Number: 6788692 ; 29) PWV2MFCPC, UDI-DI:10197106425701 (each) 50197106425709 (case), Lot Number: 6788692 ; 30) PWV2MFCPD, UDI-DI:10197106484340 (each) 50197106484348 (case), Lot Number: 7160517 ; 31) PWV2MFCPD, UDI-DI:10197106484340 (each) 50197106484348 (case), Lot Number: 7160540 ; 32) PWV2MFCPE, UDI-DI:10197106532461 (each) 50197106532469 (case), Lot Number: 7287574 ; 33) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7287574 ; 34) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7287577 ; 35) PWV2MFCPF, UDI-DI:10197106548059 (each) 50197106548057 (case), Lot Number: 7331480 ;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 6 of 12

Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;

Z-1131-2025
Recall number
Z-1131-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J4219A ; 2) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J4678M ; 3) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J53W13 ; 4) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J6277W ; 5) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J7904P ; 6) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J8491U ; 7) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J6785Z ; 8) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J6786D ; 9) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J9602P ; 10) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J96A00 ; 11) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: J96N37 ; 12) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: 5136008 ; 13) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: 5405613 ; 14) SRIET0979N, UDI-DI:10885425517206 (each) 50885425517204 (case), Lot Number: PO351726 ;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 7 of 12

Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG8 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGM 7) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGN 8) KIT,CHP SINUS ENDOSCOPY, Catalog Number:PE36ESCHA 9) KIT, SSSC ENT, Catalog Number:PECGOTSN1 10) KIT, SSSC ENT, Catalog Number:PECGOTSN2 11) KIT, SSSC ENT, Catalog Number:PECGOTSN3 12) KIT, SSSC ENT, Catalog Number:PECGOTSNA 13) KIT, SSSC ENT, Catalog Number:PECGOTSNB 14) KIT, SSSC ENT, Catalog Number:PECGOTSNC 15) KIT, SSSC ENT, Catalog Number:PECGOTSND 16) KIT, SSSC ENT, Catalog Number:PECGOTSNE 17) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10O 18) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10P 19) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10Q 20) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10R 21) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10S 22) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10T 23) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA10Y 24) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA110 25) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA112 26) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA113 27) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA114 28) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA115 29) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA116 30) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA117 31) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA118 32) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA119 33) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA120 34) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA121 35) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA123 36) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA124 37) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA125 38) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA126 39) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA127 40) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA128 41) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA129 42) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT101 43) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10A 44) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10B 45) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10D 46) KIT, MINOR ENT, MERCY, Catalog Number:PEVNMECHE 47) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PGV2OT10C 48) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH1 49) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH2 50) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH3 51) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCHA 52) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC1 53) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC2 54) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCB 55) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPCC 56) ENDO SSOP PACK, Catalog Number:SBA23ENPCD 57) L T P PACK, Catalog Number:SEN11LTCH3 58) L T P PACK, Catalog Number:SEN11LTCH4 59) ENT PACK, Catalog Number:SEN12NSHHT 60) ENT PACK, Catalog Number:SEN12NSHHU 61) ENT, Catalog Number:SEN13ENRU5 62) ENT, Catalog Number:SEN13ENRU6 63) ENT, Catalog Number:SEN13ENRUH 64) NASAL PACK, Catalog Number:SEN13NSCOH 65) NASAL PACK, Catalog Number:SEN13NSCOI 66) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT3 67) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNT4 68) RHINOPLASTY NASAL PACK, Catalog Number:SEN13RNNTJ 69) SINUS ENT PACK, Catalog Number:SEN13SNNT1 70) SINUS ENT PACK, Catalog Number:SEN13SNNT2 71) SINUS ENT PACK, Catalog Number:SEN13SNNT3 72) STERILE SINUS ENT PACK, Catalog Number:SEN13SNNTL 73) ENT PACK, Catalog Number:SEN21EPHO1 74) ENT PACK, Catalog Number:SEN21EPHO2 75) ENT PACK, Catalog Number:SEN21EPHO3 76) ENT PACK, Cata

Z-1132-2025
Recall number
Z-1132-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) PE29NSFG4, UDI-DI:10195594302870 (each) 50195594302878 (case), Lot Number: 5140385 ; 2) PE29NSFG5, UDI-DI:10195594429980 (each) 50195594429988 (case), Lot Number: 5478805 ; 3) PE29NSFG6, UDI-DI:10195594510046 (each) 50195594510044 (case), Lot Number: 5664108 ; 4) PE29NSFG7, UDI-DI:10197106511206 (each) 50197106511204 (case), Lot Number: 7280115 ; 5) PE29NSFG8, UDI-DI:10197106535981 (each) 50197106535989 (case), Lot Number: 7320240 ; 6) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J3593N ; 7) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J46C07 ; 8) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J4952P ; 9) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679N ; 10) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679T ; 11) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J7905H ; 12) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6701854 ; 13) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7005491 ; 14) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7266056 ; 15) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7280114 ; 16) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J84K06 ; 17) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693H ; 18) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693K ; 19) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J6368Z ; 20) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 21) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 22) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5841390 ; 23) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5533340 ; 24) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6025794 ; 25) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6487916 ; 26) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6487917 ; 27) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6563985 ; 28) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6788522 ; 29) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7287564 ; 30) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7349687 ; 31) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7360443 ; 32) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6487899 ; 33) PECGOTSN1, UDI-DI:10195594910358 (each) 50195594910356 (case), Lot Number: J6278X ; 34) PECGOTSN2, UDI-DI:10195594573386 (each) 50195594573384 (case), Lot Number: 5841390 ; 35) PECGOTSN3, UDI-DI:10197106422984 (each) 50197106422982 (case), Lot Number: 7163105 ; 36) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J30T07 ; 37) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J46C05 ; 38) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J4952N ; 39) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J4952P ; 40) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J4952U ; 41) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J5679N ; 42) PECGOTSNC, UDI-DI:10888439809640 (each) 50888439809648 (case), Lot Number: J6050A ; 43) PECGOTSNC, UDI-DI:10888439809640 (each) 50888439809648 (case), Lot Number: J70X23 ; 44) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J84K05 ; 45) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J85W32 ; 46) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J9850D ; 47) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5140379 ; 48) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5508060 ; 49) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5631078 ; 50) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5533340 ; 51) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 6025793 ; 52) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7331349 ; 53) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7163035 ; 54) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7280115 ; 55) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7320240 ; 56) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7331347 ; 57) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7332919 ; 58) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7320243 ; 59) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7280113 ; 60) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7349697 ; 61) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7349699 ; 62) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 6487917 ; 63) PEV2EA10O, UDI-DI:10888439393095 (each) 50888439393093 (case), Lot Number: J43W11 ; 64) PEV2EA10O, UDI-DI:10888439393095 (each) 50888439393093 (case), Lot Number: J43W11 ; 65) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J43W11 ; 66) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J43W12 ; 67) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J4952X ; 68) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J4952Z ; 69) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J6278Y ; 70) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J8241C ; 71) PEV2EA10R, UDI-DI:10888439941593 (each) 50888439941591 (case), Lot Number: J7708N ; 72) PEV2EA10S, UDI-DI:10888439967425 (each) 50888439967423 (case), Lot Number: J8998N ; 73) PEV2EA10S, UDI-DI:10888439967425 (each) 50888439967423 (case), Lot Number: J7128Y ; 74) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5533345 ; 75) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5664110 ; 76) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5664110 ; 77) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5140386 ; 78) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6022144 ; 79) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6416696 ; 80) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6560951 ; 81) PEV2EA10Y, UDI-DI:10197106546734 (each) 50197106546732 (case), Lot Number: 7333439 ; 82) PEV2EA110, UDI-DI:10195594947125 (each) 50195594947123 (case), Lot Number: J7708P ; 83) PEV2EA112, UDI-DI:10195594456498 (each) 50195594456496 (case), Lot Number: 5140387 ; 84) PEV2EA113, UDI-DI:10195594545642 (each) 50195594545640 (case), Lot Number: 5140387 ; 85) PEV2EA114, UDI-DI:10195594813864 (each) 50195594813862 (case), Lot Number: 6025795 ; 86) PEV2EA115, UDI-DI:10195594859602 (each) 50195594859600 (case), Lot Number: 6279861 ; 87) PEV2EA116, UDI-DI:10197106174913 (each) 50197106174911 (case), Lot Number: 6560950 ; 88) PEV2EA117, UDI-DI:10197106258132 (each) 50197106258130 (case), Lot Number: 6702037 ; 89) PEV2EA118, UDI-DI:10197106289266 (each) 50197106289264 (case), Lot Number: 6702037 ; 90) PEV2EA119, UDI-DI:10197106392294 (each) 50197106392292 (case), Lot Number: 6568688 ; 91) PEV2EA120, UDI-DI:10197106429273 (each) 50197106429271 (case), Lot Number: 7005492 ; 92) PEV2EA121, UDI-DI:10197106479285 (each) 50197106479283 (case), Lot Number: 6560950 ; 93) PEV2EA123, UDI-DI:10197106593875 (each) 50197106593873 (case), Lot Number: 7331477 ; 94) PEV2EA124, UDI-DI:10197106615096 (each) 50197106615094 (case), Lot Number: 7331477 ; 95) PEV2EA125, UDI-DI:10197106626955 (each) 50197106626953 (case), Lot Number: 7331478 ; 96) PEV2EA126, UDI-DI:10197106669181 (each) 50197106669189 (case), Lot Number: 7331478 ; 97) PEV2EA127, UDI-DI:10197106674475 (each) 50197106674473 (case), Lot Number: 7333440 ; 98) PEV2EA128, UDI-DI:10197106715673 (each) 50197106715671 (case), Lot Number: 7333440 ; 99) PEV2EA128, UDI-DI:10197106715673 (each) 50197106715671 (case), Lot Number: 7333441 ; 100) PEV2EA129, UDI-DI:10197106739129 (each) 50197106739127 (case), Lot Number: 7333441 ; 101) PEV2OT101, UDI-DI:10195594008024 (each) 50195594008022 (case), Lot Number: J96A02 ; 102) PEV2OT10A, UDI-DI:10888439619072 (each) 50888439619070 (case), Lot Number: J4679J ; 103) PEV2OT10A, UDI-DI:10888439619072 (each) 50888439619070 (case), Lot Number: J4680A ; 104) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J4950Z ; 105) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J53W12 ; 106) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J7412G ; 107) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J77Z27 ; 108) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J82M03 ; 109) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J8393C ; 110) PEV2OT10D, UDI-DI:10888439967401 (each) 50888439967409 (case), Lot Number: J96A01 ; 111) PEVNMECHE, UDI-DI:10887488683201 (each) 50887488683209 (case), Lot Number: J5679T ; 112) PGV2OT10C, UDI-DI:10888439393071 (each) 50888439393079 (case), Lot Number: J4678Z ; 113) PGVMCLCH1, UDI-DI:10888439691290 (each) 50888439691298 (case), Lot Number: J46C12 ; 114) PGVMCLCH2, UDI-DI:10197106459195 (each) 50197106459193 (case), Lot Number: 7160518 ; 115) PGVMCLCH3, UDI-DI:10197106525593 (each) 50197106525591 (case), Lot Number: 7163124 ; 116) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 7360541 ; 117) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6788692 ; 118) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 7287574 ; 119) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J4220A ; 120) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J43W15 ; 121) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6022K ; 122) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6372Z ; 123) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J8241D ; 124) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J4953F ; 125) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J84K11 ; 126) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J87C82 ; 127) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5136000 ; 128) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5140389 ; 129) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6935J ; 130) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6935H ; 131) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: I2131399 ; 132) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5664113 ; 133) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J65K18 ; 134) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J65K19 ; 135) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5876884 ; 136) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6251077 ; 137) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6251076 ; 138) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6560956 ; 139) SBA23ENPC1, UDI-DI:10195594699147 (each) 50195594699145 (case), Lot Number: 6022125 ; 140) SBA23ENPC2, UDI-DI:10195594815240 (each) 50195594815248 (case), Lot Number: 6364779 ; 141) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J34J40 ; 142) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J3986W ; 143) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 9205151 ; 144) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J3987A ; 145) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J4878A ; 146) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J53W60 ; 147) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J7499K ; 148) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: N/A ; 149) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J79H41 ; 150) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J7905C ; 151) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J8393N ; 152) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J84J98 ; 153) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J85W22 ; 154) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J8693G ; 155) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J9424T ; 156) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: J9699W ; 157) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 5140341 ; 158) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 5631067 ; 159) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 5664097 ; 160) SBA23ENPCB, UDI-DI:10888439615883 (each) 50888439615881 (case), Lot Number: 5775807 ; 161) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6563985 ; 162) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6702007 ; 163) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6756889 ; 164) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6914937 ; 165) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6914939 ; 166) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6914940 ; 167) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 5775809 ; 168) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6416686 ; 169) SBA23ENPCC, UDI-DI:10195594642099 (each) 50195594642097 (case), Lot Number: 6416691 ; 170) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7163032 ; 171) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7280102 ; 172) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7280102 ; 173) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7163102 ; 174) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7331335 ; 175) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7332901 ; 176) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7332898 ; 177) SBA23ENPCD, UDI-DI:10197106415375 (each) 50197106415373 (case), Lot Number: 7360446 ; 178) SEN11LTCH3, UDI-DI:10197106198490 (each) 50197106198498 (case), Lot Number: 6907761 ; 179) SEN11LTCH4, UDI-DI:10197106203798 (each) 50197106203796 (case), Lot Number: 6701894 ; 180) SEN12NSHHT, UDI-DI:10888439281118 (each) 50888439281116 (case), Lot Number: J65K12 ; 181) SEN12NSHHU, UDI-DI:10195594971410 (each) 50195594971418 (case), Lot Number: J9424M ; 182) SEN12NSHHU, UDI-DI:10195594971410 (each) 50195594971418 (case), Lot Number: J9424M ; 183) SEN13ENRU5, UDI-DI:10888439683240 (each) 50888439683248 (case), Lot Number: J4952U ; 184) SEN13ENRU6, UDI-DI:10888439758528 (each) 50888439758526 (case), Lot Number: J53W79 ; 185) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7163105 ; 186) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6702034 ; 187) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6779961 ; 188) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6788669 ; 189) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7266056 ; 190) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7280115 ; 191) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7331347 ; 192) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7332921 ; 193) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J37U13 ; 194) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 7332924 ; 195) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J46C08 ; 196) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J5679R ; 197) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J5679R ; 198) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J76D61 ; 199) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J84K05 ; 200) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J85W31 ; 201) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J85W32 ; 202) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J9197G ; 203) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 52602505 ; 204) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J9602U ; 205) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 202008020-KSH ; 206) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: J9197H ; 207) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5135998 ; 208) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5140379 ; 209) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5533339 ; 210) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5631078 ; 211) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5841390 ; 212) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5533340 ; 213) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 5664106 ; 214) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6022136 ; 215) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6264574 ; 216) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6487916 ; 217) SEN13ENRUH, UDI-DI:10887488447186 (each) 50887488447184 (case), Lot Number: 6702023 ; 218) SEN13NSCOH, UDI-DI:10888439925470 (each) 50888439925478 (case), Lot Number: 5136019 ; 219) SEN13NSCOH, UDI-DI:10888439925470 (each) 50888439925478 (case), Lot Number: 5140357 ; 220) SEN13NSCOI, UDI-DI:10195594613983 (each) 50195594613981 (case), Lot Number: 5858464 ; 221) SEN13NSCOI, UDI-DI:10195594613983 (each) 50195594613981 (case), Lot Number: 6133661 ; 222) SEN13RNNT3, UDI-DI:10888439751352 (each) 50888439751350 (case), Lot Number: J53W79 ; 223) SEN13RNNT4, UDI-DI:10195594354961 (each) 50195594354969 (case), Lot Number: 5405629 ; 224) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J30T08 ; 225) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J37U13 ; 226) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J43U80 ; 227) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J43U78 ; 228) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: 2739AC1 ; 229) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J4952U ; 230) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J53W78 ; 231) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J43U80 ; 232) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: J9850D ; 233) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: 5140378 ; 234) SEN13RNNTJ, UDI-DI:10885425604005 (each) 50885425604003 (case), Lot Number: 5508060 ; 235) SEN13SNNT1, UDI-DI:10888439756302 (each) 50888439756300 (case), Lot Number: J53W77 ; 236) SEN13SNNT2, UDI-DI:10195594910778 (each) 50195594910776 (case), Lot Number: J6278W ; 237) SEN13SNNT3, UDI-DI:10195594412692 (each) 50195594412690 (case), Lot Number: 5533340 ; 238) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J30T05 ; 239) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J37U14 ; 240) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J43U80 ; 241) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J46C08 ; 242) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J4952P ; 243) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J4952U ; 244) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J53W78 ; 245) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J7964A ; 246) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J7905J ; 247) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J8693J ; 248) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J8693M ; 249) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J6368U ; 250) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: J9602W ; 251) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: 5140357 ; 252) SEN13SNNTL, UDI-DI:10885425603985 (each) 50885425603983 (case), Lot Number: 5140385 ; 253) SEN21EPHO1, UDI-DI:10195594918828 (each) 50195594918826 (case), Lot Number: J6368Z ; 254) SEN21EPHO2, UDI-DI:10195594476632 (each) 50195594476630 (case), Lot Number: 5631077 ; 255) SEN21EPHO3, UDI-DI:10195594806651 (each) 50195594806659 (case), Lot Number: 6264574 ; 256) SEN21EPHOA, UDI-DI:10888439974140 (each) 50888439974148 (case), Lot Number: 5136019 ; 257) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: J98T17 ; 258) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: J9850D ; 259) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 0301B61 ; 260) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 5405629 ; 261) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 5508060 ; 262) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 5664107 ; 263) SEN21EPHOB, UDI-DI:10195594142636 (each) 50195594142634 (case), Lot Number: 5858464 ; 264) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6702023 ; 265) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6788671 ; 266) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 7160529 ; 267) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 7163149 ; 268) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 5970335 ; 269) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 5970337 ; 270) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6025793 ; 271) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6560949 ; 272) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6560949 ; 273) SEN21EPHOC, UDI-DI:10195594607159 (each) 50195594607157 (case), Lot Number: 6560949 ; 274) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7160538 ; 275) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7280113 ; 276) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7266056 ; 277) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7280116 ; 278) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7320241 ; 279) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7331346 ; 280) SEN21EPHOD, UDI-DI:10197106459980 (each) 50197106459988 (case), Lot Number: 7280114 ; 281) SEN21EPHOE, UDI-DI:10197106783146 (each) 50197106783144 (case), Lot Number: 7332925 ; 282) SEN23BRDU1, UDI-DI:10195594015176 (each) 50195594015174 (case), Lot Number: J9601Y ; 283) SEN23BRDU2, UDI-DI:10195594205584 (each) 50195594205582 (case), Lot Number: J9699R ; 284) SEN23BRDU3, UDI-DI:10195594289676 (each) 50195594289674 (case), Lot Number: 5140306 ; 285) SEN23BRDU3, UDI-DI:10195594289676 (each) 50195594289674 (case), Lot Number: 5145998 ; 286) SEN23BRDU4, UDI-DI:10195594368913 (each) 50195594368911 (case), Lot Number: 5405624 ; 287) SEN23BRDU5, UDI-DI:10197106242063 (each) 50197106242061 (case), Lot Number: 2291744 ; 288) SEN23BRDU5, UDI-DI:10197106242063 (each) 50197106242061 (case), Lot Number: 6568677 ; 289) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7349684 ; 290) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J19G16 ; 291) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J37U05 ; 292) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J46A89 ; 293) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6487895 ; 294) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6717951 ; 295) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7110269 ; 296) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7280095 ; 297) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7280096 ; 298) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7280097 ; 299) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7287558 ; 300) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7280096 ; 301) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7331327 ; 302) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J43U73 ; 303) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7332891 ; 304) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J4951X ; 305) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 7672 ; 306) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J53W55 ; 307) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J6366T ; 308) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J6278M ; 309) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J7704C ; 310) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J6278M ; 311) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J8393M ; 312) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J8393K ; 313) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: J97W47 ; 314) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5136014 ; 315) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 265166 ; 316) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5631064 ; 317) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5664093 ; 318) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5775805 ; 319) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 20H1983 ; 320) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 201019907SH ; 321) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5858463 ; 322) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6025777 ; 323) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 5649225 ; 324) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6416699 ; 325) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6279857 ; 326) SEN23BRDUV, UDI-DI:10888439451405 (each) 50888439451403 (case), Lot Number: 6487896 ; 327) SEN23HN55F, UDI-DI:10887488382647 (each) 50887488382645 (case), Lot Number: J16T59 ; 328) SEN23HN55F, UDI-DI:10887488382647 (each) 50887488382645 (case), Lot Number: J19G21 ; 329) SEN23HN55F, UDI-DI:10887488382647 (each)

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 8 of 12

Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC

Z-1133-2025
Recall number
Z-1133-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 6701856 ; 2) PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 7331357 ; 3) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7266123 ; 4) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7331357 ; 5) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452 ; 6) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333453 ; 7) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7160530 ; 8) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452 ; 9) PB4FRHWFC, UDI-DI:10197106732311 (each) 50197106732319 (case), Lot Number: 7350003 ;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 9 of 12

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP

Z-1134-2025
Recall number
Z-1134-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) CHIP99NC12, UDI-DI:10195594105471 (each) 50195594105479 (case), Lot Number: J8692J ; 2) CHIP99NC13, UDI-DI:10195594202378 (each) 50195594202376 (case), Lot Number: 5138245 ; 3) CHIP99NC14, UDI-DI:10195594276898 (each) 50195594276896 (case), Lot Number: 5324036 ; 4) CHIP99NC15, UDI-DI:10195594399696 (each) 50195594399694 (case), Lot Number: 5530905 ; 5) CHIP99NC16, UDI-DI:10195594444846 (each) 50195594444844 (case), Lot Number: 5530911 ; 6) CHIP99NC17, UDI-DI:10197106046159 (each) 50197106046157 (case), Lot Number: 6560930 ; 7) CHIP99NC18, UDI-DI:10197106169643 (each) 50197106169641 (case), Lot Number: 6701892 ; 8) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6264447 ; 9) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6986972 ; 10) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 7005424 ; 11) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4218Z ; 12) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4678H ; 13) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4678T ; 14) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4950P ; 15) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J53W06 ; 16) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 17) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6049N ; 18) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6365Y ; 19) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J77Z27 ; 20) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J82M02 ; 21) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 22) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J8393C ; 23) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J84J89 ; 24) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 25) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6910P ; 26) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J9602N ; 27) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5664019 ; 28) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5664026 ; 29) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5891284 ; 30) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5631036 ; 31) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6022056 ; 32) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6264450 ; 33) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6345501 ; 34) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6563903 ; 35) CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case), Lot Number: 1055391 ; 36) CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case), Lot Number: 5138240 ; 37) CHIP99NC23, UDI-DI:10195594229412 (each) 50195594229410 (case), Lot Number: 5311235 ; 38) CHIP99NC24, UDI-DI:10195594374297 (each) 50195594374295 (case), Lot Number: 5138222 ; 39) CHIP99NC25, UDI-DI:10195594416966 (each) 50195594416964 (case), Lot Number: 5530901 ; 40) CHIP99NC26, UDI-DI:10195594484736 (each) 50195594484734 (case), Lot Number: 5631034 ; 41) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7332815 ; 42) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280043 ; 43) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6264447 ; 44) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6905474 ; 45) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7058621 ; 46) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7005446 ; 47) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6701940 ; 48) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7055834 ; 49) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260062 ; 50) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260064 ; 51) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280036 ; 52) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280061 ; 53) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7160480 ; 54) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260073 ; 55) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7331292 ; 56) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7331290 ; 57) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4678H ; 58) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4679N ; 59) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4678W ; 60) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: N/A ; 61) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J5678T ; 62) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J53W12 ; 63) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6049N ; 64) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6049Y ; 65) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J77Z26 ; 66) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J7904P ; 67) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J82M03 ; 68) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J8491U ; 69) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J84J86 ; 70) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: N/A ; 71) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6365Z ; 72) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J96N39 ; 73) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6365K ; 74) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5699520 ; 75) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5699520 ; 76) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5891286 ; 77) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6485583 ; 78) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6563907 ; 79) CHIP99SP32, UDI-DI:10195594140274 (each) 50195594140272 (case), Lot Number: 5138228 ; 80) CHIP99SP33, UDI-DI:10195594229733 (each) 50195594229731 (case), Lot Number: 5311233 ; 81) CHIP99SP34, UDI-DI:10195594303280 (each) 50195594303288 (case), Lot Number: 5372220 ; 82) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6022059 ; 83) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6905475 ; 84) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7005449 ; 85) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7055834 ; 86) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7122100 ; 87) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260057 ; 88) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260066 ; 89) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260068 ; 90) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260070 ; 91) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7280037 ; 92) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260072 ; 93) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7287459 ; 94) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7287469 ; 95) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6485591 ; 96) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7332810 ; 97) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J3986J ; 98) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4678M ; 99) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7332837 ; 100) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4679H ; 101) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4950G ; 102) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7360138 ; 103) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4950U ; 104) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4951G ; 105) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: N/A ; 106) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J5678T ; 107) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J8670H ; 108) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J6785Z ; 109) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J93M83 ; 110) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5405614 ; 111) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5631031 ; 112) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5664020 ; 113) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5699520 ; 114) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6022054 ; 115) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6345500 ; 116) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6563903 ; 117) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6563910 ; 118) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6701967 ; 119) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J4680A ; 120) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J6049T ; 121) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J6277P ; 122) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J76N01 ; 123) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J7904R ; 124) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J3986G ; 125) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4678Z ; 126) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4679C ; 127) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4679G ; 128) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4680C ; 129) PN11CNC10, UDI-DI:10195594392536 (each) 50195594392534 (case), Lot Number: 5405610 ; 130) PN11CNC11, UDI-DI:10195594511968 (each) 50195594511966 (case), Lot Number: 5508042 ; 131) PN11CNC12, UDI-DI:10195594565459 (each) 50195594565457 (case), Lot Number: J6049X ; 132) PN11CNC13, UDI-DI:10195594610982 (each) 50195594610980 (case), Lot Number: 5891282 ; 133) PN11CNC14, UDI-DI:10195594774462 (each) 50195594774460 (case), Lot Number: 6022061 ; 134) PN11CNC15, UDI-DI:10195594808952 (each) 50195594808950 (case), Lot Number: 6411398 ; 135) PN11CNC16, UDI-DI:10197106329207 (each) 50197106329205 (case), Lot Number: 7005438 ; 136) PN11CNC17, UDI-DI:10197106448922 (each) 50197106448920 (case), Lot Number: 7122100 ; 137) PN11CNC18, UDI-DI:10197106529485 (each) 50197106529483 (case), Lot Number: 7280036 ; 138) PN11CNC19, UDI-DI:10197106646151 (each) 50197106646159 (case), Lot Number: 7331285 ; 139) PN11CNC20, UDI-DI:10197106800867 (each) 50197106800865 (case), Lot Number: 7365538 ; 140) PN11CNCH7, UDI-DI:10195594061531 (each) 50195594061539 (case), Lot Number: 5136008 ; 141) PN11CNCH8, UDI-DI:10195594126414 (each) 50195594126412 (case), Lot Number: 5136036 ; 142) PN11CNCH9, UDI-DI:10195594246341 (each) 50195594246349 (case), Lot Number: 5138246 ; 143) PN11CNCHN, UDI-DI:10888439472288 (each) 50888439472286 (case), Lot Number: J3986G ; 144) PN11CNCHO, UDI-DI:10888439575491 (each) 50888439575499 (case), Lot Number: J4678K ; 145) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J4949Z ; 146) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J4951A ; 147) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J53W18 ; 148) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J6365X ; 149) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J76N04 ; 150) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J82M03 ; 151) PN11CNCHQ, UDI-DI:10888439631906 (each) 50888439631904 (case), Lot Number: J6365U ; 152) PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case), Lot Number: J6910U ; 153) PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case), Lot Number: J96A00 ; 154) PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case), Lot Number: 5530913 ; 155) PN11CNCHR, UDI-DI:10195594910211 (each) 50195594910219 (case), Lot Number: 5631029 ; 156) PN11CNCHS, UDI-DI:10195594494582 (each) 50195594494580 (case), Lot Number: 5891291 ; 157) PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case), Lot Number: 6907768 ; 158) PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case), Lot Number: 6485580 ; 159) PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case), Lot Number: 6687084 ; 160) PN11CNCHT, UDI-DI:10195594760090 (each) 50195594760098 (case), Lot Number: 6687083 ; 161) PN11CNCHU, UDI-DI:10197106307496 (each) 50197106307494 (case), Lot Number: 7260062 ; 162) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7287465 ; 163) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7331284 ; 164) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7331283 ; 165) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7331456 ; 166) PN11CNCHV, UDI-DI:10197106550212 (each) 50197106550210 (case), Lot Number: 7332825 ; 167) PN11NEXX2, UDI-DI:10195594290368 (each) 50195594290366 (case), Lot Number: 5324047 ; 168) PN11NEXX3, UDI-DI:10195594586072 (each) 50195594586070 (case), Lot Number: 5664035 ; 169) PN11NEXX4, UDI-DI:10197106006191 (each) 50197106006199 (case), Lot Number: 6485583 ; 170) PN11NEXX5, UDI-DI:10197106589069 (each) 50197106589067 (case), Lot Number: 7287456 ; 171) PN11NEXX6, UDI-DI:10197106714799 (each) 50197106714797 (case), Lot Number: 7332807 ; 172) PN11NEXX7, UDI-DI:10197106725498 (each) 50197106725496 (case), Lot Number: 7332815 ; 173) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J6049W ; 174) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J6277M ; 175) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J76N03 ; 176) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J7962U ; 177) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J8392Z ; 178) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J90H78 ; 179) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J6786G ; 180) PN11NEXXB, UDI-DI:10888439786996 (each) 50888439786994 (case), Lot Number: J70X16 ; 181) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5135980 ; 182) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5138245 ; 183) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5 ; 184) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5530889 ; 185) PN11NEXXD, UDI-DI:10195594975043 (each) 50195594975041 (case), Lot Number: 5631031 ; 186) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6907761 ; 187) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7058621 ; 188) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7122004 ; 189) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6907748 ; 190) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7055836 ; 191) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7160474 ; 192) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7260069 ; 193) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 7287472 ; 194) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6560923 ; 195) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: J6365M ; 196) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 5891296 ; 197) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6022052 ; 198) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6264450 ; 199) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6687061 ; 200) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6687082 ; 201) PN11NEXXE, UDI-DI:10195594483074 (each) 50195594483072 (case), Lot Number: 6701945 ; 202) PN11OTR10, UDI-DI:10197106121214 (each) 50197106121212 (case), Lot Number: 6560956 ; 203) PN11OTR11, UDI-DI:10197106238080 (each) 50197106238088 (case), Lot Number: 6702040 ; 204) PN11OTR12, UDI-DI:10197106342343 (each) 50197106342341 (case), Lot Number: 6702040 ; 205) PN11OTR13, UDI-DI:10197106419526 (each) 50197106419524 (case), Lot Number: 6806122 ; 206) PN11OTR14, UDI-DI:10197106560525 (each) 50197106560523 (case), Lot Number: 7287574 ; 207) PN11OTRM1, UDI-DI:10195594004057 (each) 50195594004055 (case), Lot Number: J8998R ; 208) PN11OTRM2, UDI-DI:10195594177089 (each) 50195594177087 (case), Lot Number: 5140388 ; 209) PN11OTRM3, UDI-DI:10195594276294 (each) 50195594276292 (case), Lot Number: 5140390 ; 210) PN11OTRM4, UDI-DI:10195594412296 (each) 50195594412294 (case), Lot Number: 5533344 ; 211) PN11OTRM5, UDI-DI:10195594494964 (each) 50195594494962 (case), Lot Number: J65K19 ; 212) PN11OTRM7, UDI-DI:10195594687755 (each) 50195594687753 (case), Lot Number: 5918342 ; 213) PN11OTRM8, UDI-DI:10195594758905 (each) 50195594758903 (case), Lot Number: 6251073 ; 214) PN11OTRM9, UDI-DI:10197106055694 (each) 50197106055692 (case), Lot Number: 6345528 ; 215) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J3593P ; 216) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J4220C ; 217) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J43W15 ; 218) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J46C10 ; 219) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J4953C ; 220) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J4953F ; 221) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J6022K ; 222) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J6022K ; 223) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J6373A ; 224) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J7708T ; 225) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J79Z50 ; 226) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J4953F ; 227) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J79Z51 ; 228) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J87C82 ; 229) PN11OTRMQ, UDI-DI:885425913827 (each) 50885425913822 (case), Lot Number: J8998R ; 230) PN11OTRMR, UDI-DI:10195594238391 (each) 50195594238399 (case), Lot Number: 5858469 ; 231) PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case), Lot Number: 6251078 ; 232) PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case), Lot Number: 6251076 ; 233) PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case), Lot Number: 6345528 ; 234) PN11OTRMS, UDI-DI:10195594713362 (each) 50195594713360 (case), Lot Number: 6560956 ; 235) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7160540 ; 236) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7160540 ; 237) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7287574 ; 238) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7163125 ; 239) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7287580 ; 240) PN11OTRMV, UDI-DI:10197106337677 (each) 50197106337675 (case), Lot Number: 7331480 ; 241) PN11OTRMW, UDI-DI:10197106653715 (each) 50197106653713 (case), Lot Number: 7333447 ; 242) PN11SHCH5, UDI-DI:10888439651652 (each) 50888439651650 (case), Lot Number: J4680D ; 243) PN11SHCH5, UDI-DI:10888439651652 (each) 50888439651650 (case), Lot Number: J4950P ; 244) PN11SHCH6, UDI-DI:10888439799217 (each) 50888439799215 (case), Lot Number: J6277R ; 245) PN11SHCH7, UDI-DI:10888439845044 (each) 50888439845042 (case), Lot Number: J74A18 ; 246) PN11SHCHQ, UDI-DI:10888439472011 (each) 50888439472019 (case), Lot Number: J4219A ; 247) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J4679X ; 248) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J4679Z ; 249) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J4680H ; 250) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J4950H ; 251) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J74A18 ; 252) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J82K97 ; 253) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J8123N ; 254) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J82K96 ; 255) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J6365U ; 256) PN11SHCHR, UDI-DI:10888439626360 (each) 50888439626368 (case), Lot Number: J6910U ; 257) PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case), Lot Number: 6701948 ; 258) PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case), Lot Number: 6470296 ; 259) PN15LSR10, UDI-DI:10197106120965 (each) 50197106120963 (case), Lot Number: 6560949 ; 260) PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case), Lot Number: 6907770 ; 261) PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case), Lot Number: 6748354 ; 262) PN15LSR11, UDI-DI:10197106274262 (each) 50197106274260 (case), Lot Number: 6788668 ; 263) PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case), Lot Number: 7280050 ; 264) PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case), Lot Number: 7332858 ; 265) PN15LSR12, UDI-DI:10197106668764 (each) 50197106668762 (case), Lot Number: 7269982 ; 266) PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case), Lot Number: 6560923 ; 267) PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case), Lot Number: 7331313 ; 268) PN15LSR13, UDI-DI:10197106685075 (each) 50197106685073 (case), Lot Number: 7365541 ; 269) PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case), Lot Number: 7332814 ; 270) PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case), Lot Number: 7331319 ; 271) PN15LSR14, UDI-DI:10197106723753 (each) 50197106723751 (case), Lot Number: 7332923 ; 272) PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case), Lot Number: 7102720 ; 273) PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case), Lot Number: 7332876 ; 274) PN15LSR15, UDI-DI:10197106793602 (each) 50197106793600 (case), Lot Number: 7163123 ; 275) PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case), Lot Number: J9602R ; 276) PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case), Lot Number: J8045P ; 277) PN15LSRM1, UDI-DI:10195594067021 (each) 50195594067029 (case), Lot Number: J9197H ; 278) PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case), Lot Number: 5136036 ; 279) PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case), Lot Number: 5136012 ; 280) PN15LSRM2, UDI-DI:10195594128050 (each) 50195594128058 (case), Lot Number: J9850D ; 281) PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case), Lot Number: 5311242 ; 282) PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case), Lot Number: J9699Y ; 283) PN15LSRM3, UDI-DI:10195594239121 (each) 50195594239129 (case), Lot Number: 5140379 ; 284) PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case), Lot Number: 5324040 ; 285) PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case), Lot Number: 5405620 ; 286) PN15LSRM4, UDI-DI:10195594338886 (each) 50195594338884 (case), Lot Number: 5140385 ; 287) PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case), Lot Number: 5405614 ; 288) PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case), Lot Number: 5138334 ; 289) PN15LSRM5, UDI-DI:10195594393373 (each) 50195594393371 (case), Lot Number: 5533338 ; 290) PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case), Lot Number: 5631025 ; 291) PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case), Lot Number: 5631060 ; 292) PN15LSRM6, UDI-DI:10195594495954 (each) 50195594495952 (case), Lot Number: 5478805 ; 293) PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case), Lot Number: J53W15 ; 294) PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case), Lot Number: 5508051 ; 295) PN15LSRM7, UDI-DI:10195594561451 (each) 50195594561459 (case), Lot Number: 5664107 ; 296) PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case), Lot Number: 6563903 ; 297) PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case), Lot Number: 6416680 ; 298) PN15LSRM8, UDI-DI:10197106017180 (each) 50197106017188 (case), Lot Number: 6345527 ; 299) PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case), Lot Number: 6687061 ; 300) PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case), Lot Number: 6416681 ; 301) PN15LSRM9, UDI-DI:10197106077801 (each) 50197106077809 (case), Lot Number: 6487917 ; 302) PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case), Lot Number: 5891284 ; 303) PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case), Lot Number: 5891299 ; 304) PN15LSRMC, UDI-DI:10195594447052 (each) 50195594447050 (case), Lot Number: 5858465 ; 305) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6701937 ; 306) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6701850 ; 307) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6702035 ; 308) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 7005434 ; 309) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 7005438 ; 310) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6748356 ; 311) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6779959 ; 312) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 7005433 ; 313) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6775067 ; 314) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 7160529 ; 315) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5664021 ; 316) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5891300 ; 317) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5970336 ; 318) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5891292 ; 319) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5891299 ; 320) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5664106 ; 321) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6022055 ; 322) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6232004 ; 323) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6025794 ; 324) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6183268 ; 325) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6345511 ; 326) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6025793 ; 327) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 5530907 ; 328) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6416678 ; 329) PN15LSRMD, UDI-DI:10195594612689 (each) 50195594612687 (case), Lot Number: 6487906 ; 330) PN15LSRME, UDI-DI:10197106409206 (each

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 10 of 12

Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUD 40) KIT, LAMINECTOMY, Catalog Number:PN41LMMYA 41) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA1 42) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA2 43) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA3 44) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA4 45) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU2 46) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU3 47) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU4 48) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU5 49) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU6 50) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU7 51) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAUJ 52) KIT, SPINE, Catalog Number:PNCGKSPI1 53) KIT, ACDF, Catalog Number:PNMVASNL1 54) KIT, ACDF, Catalog Number:PNMVASNL2 55) KIT, ACDF, Catalog Number:PNMVASNLA 56) KIT, ACDF, Catalog Number:PNMVASNLB 57) KIT, ACDF, Catalog Number:PNMVASNLC 58) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL2 59) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL3 60) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLA 61) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLB 62) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLC 63) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLD 64) KIT, SPINE FUSION, Catalog Number:PNMVSF454 65) KIT, SPINE FUSION, Catalog Number:PNMVSF45A 66) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA1 67) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA2 68) KIT,CRANIOTOMY, Catalog Number:PNOCCRZAA 69) KIT,LAMINECTOMY, Catalog Number:PNOCLAZA1 70) KIT,LAMINECTOMY, Catalog Number:PNOCLAZAA 71) KIT, LAMINECTOMY, Catalog Number:PNOCLAZAB 72) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH11 73) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH12 74) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH13 75) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH14 76) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH15 77) SPINE, HUNTINGTON, Catalog Number:PNOCSPHTU 78) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTV 79) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTW 80) KIT, ORTHO C

Z-1135-2025
Recall number
Z-1135-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
793,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) CHIP99SP11, UDI-DI:10195594137595 (each) 50195594137593 (case), Lot Number: 5138229 ; 2) CHIP99SP12, UDI-DI:10195594268466 (each) 50195594268464 (case), Lot Number: 5324036 ; 3) CHIP99SP13, UDI-DI:10197106271377 (each) 50197106271375 (case), Lot Number: 6907769 ; 4) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7045815 ; 5) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280043 ; 6) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701891 ; 7) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701938 ; 8) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6986974 ; 9) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7005449 ; 10) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7055825 ; 11) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7160425 ; 12) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7260062 ; 13) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280062 ; 14) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7287465 ; 15) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6485588 ; 16) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7331290 ; 17) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4218Z ; 18) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678H ; 19) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678J ; 20) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332809 ; 21) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678P ; 22) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332837 ; 23) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332837 ; 24) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4680D ; 25) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J53W07 ; 26) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J53W10 ; 27) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6049N ; 28) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6277R ; 29) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: N/A ; 30) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6277W ; 31) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6365T ; 32) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J72P49 ; 33) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J72P49 ; 34) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J82K97 ; 35) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: N/A ; 36) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J8123N ; 37) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J8393C ; 38) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J93M83 ; 39) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5372220 ; 40) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5530888 ; 41) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5530904 ; 42) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5631043 ; 43) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5664019 ; 44) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6049X ; 45) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5699520 ; 46) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5775787 ; 47) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5775788 ; 48) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6025763 ; 49) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6022051 ; 50) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6264448 ; 51) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6183268 ; 52) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6411401 ; 53) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6485582 ; 54) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6560931 ; 55) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701948 ; 56) CHIP99SP22, UDI-DI:10195594006723 (each) 50195594006721 (case), Lot Number: J96N37 ; 57) CHIP99SP23, UDI-DI:10195594158040 (each) 50195594158048 (case), Lot Number: 5138235 ; 58) CHIP99SP24, UDI-DI:10195594307745 (each) 50195594307743 (case), Lot Number: 5508040 ; 59) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7280043 ; 60) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6264449 ; 61) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6905474 ; 62) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7005424 ; 63) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7121998 ; 64) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6701940 ; 65) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7055833 ; 66) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7122072 ; 67) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7122098 ; 68) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7160425 ; 69) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7286183 ; 70) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7280044 ; 71) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7260072 ; 72) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7287471 ; 73) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7348991 ; 74) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4218Z ; 75) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7332810 ; 76) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4678X ; 77) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4679T ; 78) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4950P ; 79) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4950W ; 80) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J53W19 ; 81) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: N/A ; 82) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6049M ; 83) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6277P ; 84) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J68T51 ; 85) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J7412G ; 86) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J72P49 ; 87) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: PO962497 ; 88) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530888 ; 89) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530911 ; 90) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5631040 ; 91) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6049Z ; 92) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J53W15 ; 93) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5775787 ; 94) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5664021 ; 95) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6022055 ; 96) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6345502 ; 97) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530909 ; 98) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6563906 ; 99) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6563795 ; 100) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6687065 ; 101) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7280076 ; 102) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287537 ; 103) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287473 ; 104) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7331317 ; 105) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287463 ; 106) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287534 ; 107) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7332810 ; 108) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7332870 ; 109) PN29PSLM4, UDI-DI:10195594301002 (each) 50195594301000 (case), Lot Number: 5324048 ; 110) PN29PSLM5, UDI-DI:10195594592653 (each) 50195594592651 (case), Lot Number: 5664025 ; 111) PN29PSLM6, UDI-DI:10195594632403 (each) 50195594632401 (case), Lot Number: 5775787 ; 112) PN29PSLM7, UDI-DI:10195594728694 (each) 50195594728692 (case), Lot Number: 6025764 ; 113) PN29PSLM8, UDI-DI:10197106531891 (each) 50197106531899 (case), Lot Number: 7160479 ; 114) PN29PSLM9, UDI-DI:10197106567555 (each) 50197106567553 (case), Lot Number: 7280061 ; 115) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: J7267D ; 116) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5405610 ; 117) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5530908 ; 118) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5631042 ; 119) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: J6365M ; 120) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5891291 ; 121) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6701938 ; 122) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6986974 ; 123) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 7005426 ; 124) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6264449 ; 125) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6485573 ; 126) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6563906 ; 127) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6568661 ; 128) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6568661 ; 129) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7122097 ; 130) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7284052 ; 131) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7160478 ; 132) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7287472 ; 133) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7287463 ; 134) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7332814 ; 135) PN33BPC10, UDI-DI:10197106682050 (each) 50197106682058 (case), Lot Number: 6485591 ; 136) PN33BPC10, UDI-DI:10197106682050 (each) 50197106682058 (case), Lot Number: 6485594 ; 137) PN33BPC11, UDI-DI:10197106717301 (each) 50197106717309 (case), Lot Number: 7332810 ; 138) PN33BPC11, UDI-DI:10197106717301 (each) 50197106717309 (case), Lot Number: 7331430 ; 139) PN33BPCR1, UDI-DI:10197106027066 (each) 50197106027064 (case), Lot Number: 6563905 ; 140) PN33BPCR1, UDI-DI:10197106027066 (each) 50197106027064 (case), Lot Number: 6345505 ; 141) PN33BPCR1, UDI-DI:10197106027066 (each) 50197106027064 (case), Lot Number: 6485593 ; 142) PN33BPCR2, UDI-DI:10197106132319 (each) 50197106132317 (case), Lot Number: 6687082 ; 143) PN33BPCR2, UDI-DI:10197106132319 (each) 50197106132317 (case), Lot Number: 6701946 ; 144) PN33BPCR2, UDI-DI:10197106132319 (each) 50197106132317 (case), Lot Number: 6701957 ; 145) PN33BPCR2, UDI-DI:10197106132319 (each) 50197106132317 (case), Lot Number: 6485596 ; 146) PN33BPCR3, UDI-DI:10197106255209 (each) 50197106255207 (case), Lot Number: 6905475 ; 147) PN33BPCR3, UDI-DI:10197106255209 (each) 50197106255207 (case), Lot Number: 6701848 ; 148) PN33BPCR4, UDI-DI:10197106505847 (each) 50197106505845 (case), Lot Number: 7260068 ; 149) PN33BPCR4, UDI-DI:10197106505847 (each) 50197106505845 (case), Lot Number: 7280083 ; 150) PN33BPCR5, UDI-DI:10197106531556 (each) 50197106531554 (case), Lot Number: 7160479 ; 151) PN33BPCR5, UDI-DI:10197106531556 (each) 50197106531554 (case), Lot Number: 6701986 ; 152) PN33BPCR6, UDI-DI:10197106570272 (each) 50197106570270 (case), Lot Number: 7280062 ; 153) PN33BPCR6, UDI-DI:10197106570272 (each) 50197106570270 (case), Lot Number: 7163141 ; 154) PN33BPCR7, UDI-DI:10197106587447 (each) 50197106587445 (case), Lot Number: 7287456 ; 155) PN33BPCR7, UDI-DI:10197106587447 (each) 50197106587445 (case), Lot Number: 6701984 ; 156) PN33BPCR8, UDI-DI:10197106635476 (each) 50197106635474 (case), Lot Number: 7287482 ; 157) PN33BPCR8, UDI-DI:10197106635476 (each) 50197106635474 (case), Lot Number: 7068414 ; 158) PN33BPCR9, UDI-DI:10197106665978 (each) 50197106665976 (case), Lot Number: 6485588 ; 159) PN33BPCR9, UDI-DI:10197106665978 (each) 50197106665976 (case), Lot Number: 7331296 ; 160) PN33BPCRA, UDI-DI:10195594899110 (each) 50195594899118 (case), Lot Number: 6563907 ; 161) PN33BPCRA, UDI-DI:10195594899110 (each) 50195594899118 (case), Lot Number: 6345505 ; 162) PN33BPCRA, UDI-DI:10195594899110 (each) 50195594899118 (case), Lot Number: 6485592 ; 163) PN33BPCRA, UDI-DI:10195594899110 (each) 50195594899118 (case), Lot Number: 6560932 ; 164) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6701894 ; 165) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6568663 ; 166) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7005445 ; 167) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6701984 ; 168) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6701940 ; 169) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6325766 ; 170) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7055833 ; 171) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6701983 ; 172) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7260062 ; 173) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7068414 ; 174) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7068424 ; 175) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7055825 ; 176) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7280083 ; 177) PN33BPCRC, UDI-DI:10197106706749 (each) 50197106706747 (case), Lot Number: 7045815 ; 178) PN33BPCRC, UDI-DI:10197106706749 (each) 50197106706747 (case), Lot Number: 7332850 ; 179) PN33BPCRC, UDI-DI:10197106706749 (each) 50197106706747 (case), Lot Number: 7332845 ; 180) PN33BPCRC, UDI-DI:10197106706749 (each) 50197106706747 (case), Lot Number: 7332849 ; 181) PN33MSOCG, UDI-DI:10197106384527 (each) 50197106384525 (case), Lot Number: 6560950 ; 182) PN33MSOCG, UDI-DI:10197106384527 (each) 50197106384525 (case), Lot Number: 7005493 ; 183) PN33SAOU1, UDI-DI:10195594811389 (each) 50195594811387 (case), Lot Number: 6133659 ; 184) PN33SAOU1, UDI-DI:10195594811389 (each) 50195594811387 (case), Lot Number: 5631066 ; 185) PN33SAOU2, UDI-DI:10197106035306 (each) 50197106035304 (case), Lot Number: 6416684 ; 186) PN33SAOU2, UDI-DI:10197106035306 (each) 50197106035304 (case), Lot Number: 6416700 ; 187) PN33SAOUA, UDI-DI:10195594510862 (each) 50195594510860 (case), Lot Number: 5664049 ; 188) PN33SAOUA, UDI-DI:10195594510862 (each) 50195594510860 (case), Lot Number: 5649225 ; 189) PN33SAOUA, UDI-DI:10195594510862 (each) 50195594510860 (case), Lot Number: 6232007 ; 190) PN33SAOUA, UDI-DI:10195594510862 (each) 50195594510860 (case), Lot Number: 6025778 ; 191) PN33SAOUB, UDI-DI:10197106090404 (each) 50197106090402 (case), Lot Number: 6470291 ; 192) PN33SAOUB, UDI-DI:10197106090404 (each) 50197106090402 (case), Lot Number: 6487896 ; 193) PN33SAOUC, UDI-DI:10197106159897 (each) 50197106159895 (case), Lot Number: 6568673 ; 194) PN33SAOUC, UDI-DI:10197106159897 (each) 50197106159895 (case), Lot Number: 6560942 ; 195) PN33SAOUC, UDI-DI:10197106159897 (each) 50197106159895 (case), Lot Number: 7269986 ; 196) PN33SAOUC, UDI-DI:10197106159897 (each) 50197106159895 (case), Lot Number: 7163118 ; 197) PN33SAOUD, UDI-DI:10197106557969 (each) 50197106557967 (case), Lot Number: 7331321 ; 198) PN33SAOUD, UDI-DI:10197106557969 (each) 50197106557967 (case), Lot Number: 7331476 ; 199) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332829 ; 200) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332807 ; 201) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332831 ; 202) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332837 ; 203) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332838 ; 204) PN69MSGA1, UDI-DI:10197106519899 (each) 50197106519897 (case), Lot Number: 7280036 ; 205) PN69MSGA1, UDI-DI:10197106519899 (each) 50197106519897 (case), Lot Number: 7287527 ; 206) PN69MSGA1, UDI-DI:10197106519899 (each) 50197106519897 (case), Lot Number: 7287561 ; 207) PN69MSGA2, UDI-DI:10197106634349 (each) 50197106634347 (case), Lot Number: 7287481 ; 208) PN69MSGA2, UDI-DI:10197106634349 (each) 50197106634347 (case), Lot Number: 7331319 ; 209) PN69MSGA2, UDI-DI:10197106634349 (each) 50197106634347 (case), Lot Number: 7332882 ; 210) PN69MSGA3, UDI-DI:10197106763889 (each) 50197106763887 (case), Lot Number: 7332838 ; 211) PN69MSGA3, UDI-DI:10197106763889 (each) 50197106763887 (case), Lot Number: 7349674 ; 212) PN69MSGA3, UDI-DI:10197106763889 (each) 50197106763887 (case), Lot Number: 7332890 ; 213) PN69MSGA4, UDI-DI:10197106803738 (each) 50197106803736 (case), Lot Number: 7280055 ; 214) PN69MSGA4, UDI-DI:10197106803738 (each) 50197106803736 (case), Lot Number: 6748353 ; 215) PN69MSGA4, UDI-DI:10197106803738 (each) 50197106803736 (case), Lot Number: 6779832 ; 216) PNCGAPAU2, UDI-DI:10888439953145 (each) 50888439953143 (case), Lot Number: J86N66 ; 217) PNCGAPAU3, UDI-DI:10195594025069 (each) 50195594025067 (case), Lot Number: J9699Z ; 218) PNCGAPAU4, UDI-DI:10195594099602 (each) 50195594099600 (case), Lot Number: 5135994 ; 219) PNCGAPAU5, UDI-DI:10195594250386 (each) 50195594250384 (case), Lot Number: J9699Y ; 220) PNCGAPAU6, UDI-DI:10195594366827 (each) 50195594366825 (case), Lot Number: 5405617 ; 221) PNCGAPAU7, UDI-DI:10195594674854 (each) 50195594674852 (case), Lot Number: 5631061 ; 222) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J37T97 ; 223) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J37T98 ; 224) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J4219R ; 225) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J46A82 ; 226) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J4877G ; 227) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J46A79 ; 228) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J8064R ; 229) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J9424N ; 230) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: 5631062 ; 231) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: 5664047 ; 232) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: 5775802 ; 233) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: 6022070 ; 234) PNCGKSPI1, UDI-DI:10195594894818 (each) 50195594894816 (case), Lot Number: 6485589 ; 235) PNCGKSPI1, UDI-DI:10195594894818 (each) 50195594894816 (case), Lot Number: 6364783 ; 236) PNMVASNL1, UDI-DI:10195594465988 (each) 50195594465986 (case), Lot Number: 5631035 ; 237) PNMVASNL1, UDI-DI:10195594465988 (each) 50195594465986 (case), Lot Number: 5565993 ; 238) PNMVASNL2, UDI-DI:10195594661670 (each) 50195594661678 (case), Lot Number: 109862 ; 239) PNMVASNL2, UDI-DI:10195594661670 (each) 50195594661678 (case), Lot Number: 5891288 ; 240) PNMVASNL2, UDI-DI:10195594661670 (each) 50195594661678 (case), Lot Number: 5140305 ; 241) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J53W17 ; 242) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J4951Y ; 243) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J53W13 ; 244) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J4951Y ; 245) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J6049Y ; 246) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J6366U ; 247) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: 219326 ; 248) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J7904N ; 249) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J7905A ; 250) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J68T47 ; 251) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J8671G ; 252) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 7752 ; 253) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J9602N ; 254) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J9601Y ; 255) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5138225 ; 256) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J9601Z ; 257) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5324041 ; 258) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5140306 ; 259) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5324041 ; 260) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5405623 ; 261) PNMVASNLC, UDI-DI:10195594471774 (each) 50195594471772 (case), Lot Number: 5631026 ; 262) PNMVASNLC, UDI-DI:10195594471774 (each) 50195594471772 (case), Lot Number: 5565993 ; 263) PNMVASNLC, UDI-DI:10195594471774 (each) 50195594471772 (case), Lot Number: 6025766 ; 264) PNMVASNLC, UDI-DI:10195594471774 (each) 50195594471772 (case), Lot Number: 6279856 ; 265) PNMVLMNL2, UDI-DI:10195594443641 (each) 50195594443649 (case), Lot Number: 5508057 ; 266) PNMVLMNL3, UDI-DI:10195594647353 (each) 50195594647351 (case), Lot Number: 5140305 ; 267) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J53W52 ; 268) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J5678J ; 269) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J6366U ; 270) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J79H50 ; 271) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J8393G ; 272) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J7905A ; 273) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J6278P ; 274) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J6366Y ; 275) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J9601X ; 276) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J9601Z ; 277) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: 5140303 ; 278) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: 7855 ; 279) PNMVLMNLC, UDI-DI:10195594224066 (each) 50195594224064 (case), Lot Number: 5140306 ; 280) PNMVLMNLC, UDI-DI:10195594224066 (each) 50195594224064 (case), Lot Number: 5405623 ; 281) PNMVLMNLC, UDI-DI:10195594224066 (each) 50195594224064 (case), Lot Number: 5478799 ; 282) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 5664093 ; 283) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 5664092 ; 284) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 6022074 ; 285) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 6279857 ; 286) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 6279859 ; 287) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 6279860 ; 288) PNMVSF454, UDI-DI:10195594275891 (each) 50195594275899 (case), Lot Number: 5324034 ; 289) PNMVSF454, UDI-DI:10195594275891 (each) 50195594275899 (case), Lot Number: 5140306 ; 290) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J6785Z ; 291) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J8671G ; 292) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J96N35 ; 293) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J8393K ; 294) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5530904 ; 295) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5405624 ; 296) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5530901 ; 297) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5405625 ; 298) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5508042 ; 299) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5631064 ; 300) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J6277X ; 301) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5649225 ; 302) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5664025 ; 303) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5664093 ; 304) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5775788 ; 305) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5858463 ; 306) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5891293 ; 307) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5918338 ; 308) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6022060 ; 309) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6022074 ; 310) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6345497 ; 311) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6025781 ; 312) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6560926 ; 313) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6279860 ; 314) PNOCCRZA1, UDI-DI:10197106554456 (each) 50197106554454 (case), Lot Number: 6701856 ; 315) PNOCCRZA2, UDI-DI:10197106573990 (each) 50197106573998 (case), Lot Number: 7287570 ; 316) PNOCCRZA2, UDI-DI:10197106573990 (each) 50197106573998 (case), Lot Number: 7266123 ; 317) PNOCCRZAA, UDI-DI:10197106307090 (each) 50197106307098 (case), Lot Number: 6702037 ; 318) PNOCCRZAA, UDI-DI:10197106307090 (each) 50197106307098 (case), Lot Number: 6788701 ; 319) PNOCCRZAA, UDI-DI:10197106307090 (each) 50197106307098 (case), Lot Number: 7331478 ; 320) PNOCCRZAA, UDI-DI:10197106307090 (each) 50197106307098 (case), Lot Number: 7331357 ; 321) PNOCLAZA1, UDI-DI:10197106576861 (each) 50197106576869 (case), Lot Number: 7287570 ; 322) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 6757045 ; 323) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 7005493 ; 324) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 6560950 ; 325) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 7160524 ; 326) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 7287570 ; 327) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 7331477 ; 328) PNOCLAZAB, UDI-DI:10197106587201 (each) 50197106587209 (case), Lot Number: 7331478 ; 329) PNOCLAZAB, UDI-DI:10197106587201 (each) 50197106587209 (case), Lot Number: 7333440 ; 330) PNOCLAZAB, UDI-DI:1019710658720

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 11 of 12

Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR PLASTIC PACK, Catalog Number:SEY35OP962 6) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96A 7) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96B 8) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96C 9) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLX 10) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLY 11) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLZ

Z-1136-2025
Recall number
Z-1136-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) SEY30EYRVA, UDI-DI:10195594159382 (each) 50195594159380 (case), Lot Number: 5140378 ; 2) SEY30EYRVB, UDI-DI:10195594555771 (each) 50195594555779 (case), Lot Number: 5970335 ; 3) SEY30EYRVB, UDI-DI:10195594555771 (each) 50195594555779 (case), Lot Number: 6133661 ; 4) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6701854 ; 5) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6702035 ; 6) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7266056 ; 7) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7280113 ; 8) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7280116 ; 9) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7320241 ; 10) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7331349 ; 11) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7331352 ; 12) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7332924 ; 13) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7332923 ; 14) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6025793 ; 15) SEY35OP961, UDI-DI:10888439702651 (each) 50888439702659 (case), Lot Number: J46C12 ; 16) SEY35OP962, UDI-DI:10888439769005 (each) 50888439769003 (case), Lot Number: J4220A ; 17) SEY35OP96A, UDI-DI:10888439626698 (each) 50888439626696 (case), Lot Number: J46C10 ; 18) SEY35OP96A, UDI-DI:10888439626698 (each) 50888439626696 (case), Lot Number: J6372Z ; 19) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J79Z51 ; 20) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: N/A ; 21) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J8393Z ; 22) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J6372Z ; 23) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6702038 ; 24) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6788692 ; 25) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6806122 ; 26) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7005495 ; 27) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7005496 ; 28) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7160517 ; 29) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7331480 ; 30) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333444 ; 31) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333444 ; 32) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333446 ; 33) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7360541 ; 34) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J87C82 ; 35) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J8998P ; 36) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5140388 ; 37) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J6935J ; 38) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5533344 ; 39) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664113 ; 40) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664113 ; 41) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J65K19 ; 42) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664115 ; 43) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5876884 ; 44) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5918342 ; 45) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6251073 ; 46) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5876884 ; 47) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6251076 ; 48) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6345528 ; 49) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6701855 ; 50) SEY35OPBLX, UDI-DI:10888439516173 (each) 50888439516171 (case), Lot Number: J28W65 ; 51) SEY35OPBLY, UDI-DI:10888439586558 (each) 50888439586556 (case), Lot Number: J4220A ; 52) SEY35OPBLZ, UDI-DI:10888439611519 (each) 50888439611517 (case), Lot Number: J4220A ;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

device · product 12 of 12

Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB

Z-1137-2025
Recall number
Z-1137-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
973,785 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Code information

1) ACDF PACK, UDI-DI:10195594353926 (each) 50195594353924 (case), Lot Number: J6935H; 2) ACDF PACK, UDI-DI:10195594439880 (each) 50195594439888 (case), Lot Number: J65K18;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.