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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95722

10 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

10 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 10

Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912; 6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913; 7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914; 8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951; 9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952; 10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953; 11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954; 12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955; 13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956; 14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957; 15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958; 16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959; 17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A; 18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C; 19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F; 20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G; 21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1; 22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2; 23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB; 24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC; 25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD; 26) DIEP PACK,Catalog Number SBA11DPS10; 27) DIEP PACK,Catalog Number SBA11DPS11; 28) DIEP PACK,Catalog Number SBA11DPS12; 29) DIEP PACK,Catalog Number SBA11DPS13; 30) DIEP PACK,Catalog Number SBA11DPS14; 31) DIEP PACK,Catalog Number SBA11DPS15; 32) DIEP PACK,Catalog Number SBA11DPS16; 33) DIEP PACK,Catalog Number SBA11DPS17; 34) DIEP PACK,Catalog Number SBA11DPS18; 35) DIEP PACK,Catalog Number SBA11DPS19; 36) DIEP PACK,Catalog Number SBA11DPS20; 37) DIEP PACK,Catalog Number SBA11DPS21; 38) DIEP PACK,Catalog Number SBA11DPS22; 39) DIEP PACK,Catalog Number SBA11DPSB4; 40) DIEP PACK,Catalog Number SBA11DPSB5; 41) DIEP PACK,Catalog Number SBA11DPSB6; 42) DIEP PACK,Catalog Number SBA11DPSB7; 43) DIEP PACK,Catalog Number SBA11DPSB8; 44) DIEP PACK,Catalog Number SBA11DPSB9; 45) DIEP PACK,Catalog Number SBA11DPSBD; 46) DIEP PACK,Catalog Number SBA11DPSBE; 47) DIEP PACK,Catalog Number SBA11DPSBF; 48) DIEP PACK,Catalog Number SBA11DPSBG; 49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1; 50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2; 51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3; 52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4; 53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5; 54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6; 55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB; 56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC; 57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD; 58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE; 59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10; 60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11; 61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12; 62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13; 63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14; 64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3; 65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4; 66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5; 67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6; 68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7; 69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8; 70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9; 71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB; 72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC; 73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF; 74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG; 75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C; 76) DIEP SIEP PACK,Catalo

Z-0908-2025
Recall number
Z-0908-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number PGHDOT951, UDI/DI 10888439692228 (EA)50888439692226 (CS), Lot Number J4952D ; Catalog Number PGHDOT952, UDI/DI 10888439821260 (EA)50888439821268 (CS), Lot Number J6050F ; Catalog Number PWHDOT910, UDI/DI 10197106435052 (EA)50197106435050 (CS), Lot Number 6788561 ; Catalog Number PWHDOT911, UDI/DI 10197106646724 (EA)50197106646722 (CS), Lot Number 7332903 ; Catalog Number PWHDOT912, UDI/DI 10197106673195 (EA)50197106673193 (CS), Lot Number 7163082 ; Catalog Number PWHDOT913, UDI/DI 10197106713365 (EA)50197106713363 (CS), Lot Number 7332912 ; Catalog Number PWHDOT914, UDI/DI 10197106718834 (EA)50197106718832 (CS), Lot Number 7332914 ; Catalog Number PWHDOT951, UDI/DI 10888439940176 (EA)50888439940174 (CS), Lot Number J84K02 ; Catalog Number PWHDOT952, UDI/DI 10195594331474 (EA)50195594331472 (CS), Lot Number J6278U ; Catalog Number PWHDOT953, UDI/DI 10195594505493 (EA)50195594505491 (CS), Lot Number 5664102 ; Catalog Number PWHDOT954, UDI/DI 10195594555559 (EA)50195594555557 (CS), Lot Number 5664101 ; Catalog Number PWHDOT955, UDI/DI 10195594646134 (EA)50195594646132 (CS), Lot Number 5891310 ; Catalog Number PWHDOT956, UDI/DI 10195594697884 (EA)50195594697882 (CS), Lot Number 5891313 ; Catalog Number PWHDOT957, UDI/DI 10197106129982 (EA)50197106129980 (CS), Lot Number 6563987 ; Catalog Number PWHDOT958, UDI/DI 10197106188095 (EA)50197106188093 (CS), Lot Number 6563989 ; Catalog Number PWHDOT959, UDI/DI 10197106329771 (EA)50197106329779 (CS), Lot Number 6701853 ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671K ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671M ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671P ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number J86T83 ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number 5405627 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6487902 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6169297 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6264570 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6264565 ; Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number 6928765 ; Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number 7163033 ; Catalog Number PWOCRHGV1, UDI/DI 10197106262788 (EA)50197106262786 (CS), Lot Number 6701852 ; Catalog Number PWOCRHGV2, UDI/DI 10197106349755 (EA)50197106349753 (CS), Lot Number 6487903 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J53W72 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J5679F ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J6050F ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J84K04 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8124A ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8671N ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8123Y ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7332915 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 22174441 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6702009 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6596397 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928759 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6806115 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928764 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928773 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7163104 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7280111 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7287567 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7280109 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7163082 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7332904 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5140347 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5664101 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891309 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891308 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891310 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891312 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number J6367H ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891313 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6022128 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6025791 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6345522 ; Catalog Number SBA11CMCPD, UDI/DI 10888439548174 (EA)50888439548172 (CS), Lot Number J3464F ; Catalog Number SBA11DPS10, UDI/DI 10195594317010 (EA)50195594317018 (CS), Lot Number 5478803 ; Catalog Number SBA11DPS11, UDI/DI 10195594401580 (EA)50195594401588 (CS), Lot Number 5478803 ; Catalog Number SBA11DPS12, UDI/DI 10195594541651 (EA)50195594541659 (CS), Lot Number 5888374 ; Catalog Number SBA11DPS13, UDI/DI 10195594615192 (EA)50195594615190 (CS), Lot Number 5891311 ; Catalog Number SBA11DPS14, UDI/DI 10195594676995 (EA)50195594676993 (CS), Lot Number 5891305 ; Catalog Number SBA11DPS15, UDI/DI 10195594795788 (EA)50195594795786 (CS), Lot Number 6025787 ; Catalog Number SBA11DPS16, UDI/DI 10195594885267 (EA)50195594885265 (CS), Lot Number 5631069 ; Catalog Number SBA11DPS17, UDI/DI 10197106193761 (EA)50197106193769 (CS), Lot Number 6560944 ; Catalog Number SBA11DPS18, UDI/DI 10197106320099 (EA)50197106320097 (CS), Lot Number 6701853 ; Catalog Number SBA11DPS19, UDI/DI 10197106369456 (EA)50197106369454 (CS), Lot Number 6806113 ; Catalog Number SBA11DPS20, UDI/DI 10197106507544 (EA)50197106507542 (CS), Lot Number 6928764 ; Catalog Number SBA11DPS21, UDI/DI 10197106584798 (EA)50197106584796 (CS), Lot Number 7163104 ; Catalog Number SBA11DPS22, UDI/DI 10197106769782 (EA)50197106769780 (CS), Lot Number 7280108 ; Catalog Number SBA11DPSB4, UDI/DI 10888439689150 (EA)50888439689158 (CS), Lot Number J53W67 ; Catalog Number SBA11DPSB5, UDI/DI 10888439763836 (EA)50888439763834 (CS), Lot Number J53W73 ; Catalog Number SBA11DPSB6, UDI/DI 10888439995633 (EA)50888439995631 (CS), Lot Number J8671M ; Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number J9602T ; Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number 1933731664 ; Catalog Number SBA11DPSB8, UDI/DI 10195594075415 (EA)50195594075413 (CS), Lot Number 5135984 ; Catalog Number SBA11DPSB9, UDI/DI 10195594211462 (EA)50195594211460 (CS), Lot Number 5136018 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J34J43 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J46A99 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J70X20 ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8393U ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8123Y ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8671K ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8692Z ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6806114 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6928758 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5631072 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5891307 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5891310 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5631071 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 55693537 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264570 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264566 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264567 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6345523 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7280111 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7287567 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7332916 ; Catalog Number SBA11MXCP1, UDI/DI 10195594114985 (EA)50195594114983 (CS), Lot Number 5140342 ; Catalog Number SBA11MXCP2, UDI/DI 10195594347819 (EA)50195594347817 (CS), Lot Number 5478804 ; Catalog Number SBA11MXCP3, UDI/DI 10195594366544 (EA)50195594366542 (CS), Lot Number J6367F ; Catalog Number SBA11MXCP4, UDI/DI 10195594416027 (EA)50195594416025 (CS), Lot Number 5533336 ; Catalog Number SBA11MXCP5, UDI/DI 10195594756369 (EA)50195594756367 (CS), Lot Number 6022131 ; Catalog Number SBA11MXCP6, UDI/DI 10195594796587 (EA)50195594796585 (CS), Lot Number 6025787 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6563989 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number J86T81 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6025787 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6264570 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6345522 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487902 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487902 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487904 ; Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number 6487901 ; Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number 6596397 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6788562 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6928760 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6928760 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332917 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7163033 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7163103 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7280107 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332910 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332906 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332907 ; Catalog Number SBA11PRH10, UDI/DI 10195594702298 (EA)50195594702296 (CS), Lot Number 5891314 ; Catalog Number SBA11PRH11, UDI/DI 10195594765477 (EA)50195594765475 (CS), Lot Number 6025786 ; Catalog Number SBA11PRH12, UDI/DI 10197106016053 (EA)50197106016051 (CS), Lot Number 6025791 ; Catalog Number SBA11PRH13, UDI/DI 10197106100172 (EA)50197106100170 (CS), Lot Number 6345522 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 157467 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 22L3440 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 6596396 ; Catalog Number SBA11PRHK3, UDI/DI 10888439745429 (EA)50888439745427 (CS), Lot Number J3464F ; Catalog Number SBA11PRHK4, UDI/DI 10888439947441 (EA)50888439947449 (CS), Lot Number J8124A ; Catalog Number SBA11PRHK5, UDI/DI 10888439992335 (EA)50888439992333 (CS), Lot Number J8692Y ; Catalog Number SBA11PRHK6, UDI/DI 10195594967062 (EA)50195594967060 (CS), Lot Number J86T83 ; Catalog Number SBA11PRHK7, UDI/DI 10195594464950 (EA)50195594464958 (CS), Lot Number 5631074 ; Catalog Number SBA11PRHK8, UDI/DI 10195594542108 (EA)50195594542106 (CS), Lot Number 5888374 ; Catalog Number SBA11PRHK9, UDI/DI 10195594659974 (EA)50195594659972 (CS), Lot Number 5891312 ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J4952D ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J5679G ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J7704H ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number J8123W ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number J84K01 ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number 5747232 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6806115 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928766 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928766 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928769 ; Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number 7332917 ; Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number 7332909 ; Catalog Number SBA12TR38C, UDI/DI 10887488792613 (EA)50887488792611 (CS), Lot Number J3987C ; Catalog Number SBA12TR38C, UDI/DI 10887488792613 (EA)50887488792611 (CS), Lot Number J4678G ; Catalog Number SBA13DSBW5, UDI/DI 10888439895087 (EA)50888439895085 (CS), Lot Number J5679K ; Catalog Number SBA13DSBW6, UDI/DI 10195594078287 (EA)50195594078285 (CS), Lot Number 5135984 ; Catalog Number SBA13DSBW7, UDI/DI 10195594128234 (EA)50195594128232 (CS), Lot Number J6367C ; Catalog Number SBA13DSBW8, UDI/DI 10195594208615 (EA)50195594208613 (CS), Lot Number 5140342 ; Catalog Number SBA13DSBW8, UDI/DI 10195594208615 (EA)50195594208613 (CS), Lot Number 5140354 ; Catalog Number SBA13DSBWF, UDI/DI 10887488334868 (EA)50887488334866 (CS), Lot Number J3464F ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J34J42 ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J43U77 ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J53W72 ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J7963G ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J7963H ; Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number J7905G ; Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number J8123Z ; Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number 2003505164 ; Catalog Number SBA13DSBWI, UDI/DI 10195594390129 (EA)50195594390127 (CS), Lot Number 5664102 ; Catalog Number SBA13DSBWI, UDI/DI 10195594390129 (EA)50195594390127 (CS), Lot Number 5664101 ; Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number 5891312 ; Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number 5891314 ; Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number 5891313 ; Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number 6022131 ; Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number 18B0346 ; Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number 18K2934 ; Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number 19A0125 ; Catalog Number SBA13TCBCD, UDI/DI 10888439177909 (EA)50888439177907 (CS), Lot Number J3464F ; Catalog Number SBA13TCBCD, UDI/DI 10888439177909 (EA)50888439177907 (CS), Lot Number J4218Z ; Catalog Number SBA53FFK10, UDI/DI 10197106338612 (EA)50197106338610 (CS), Lot Number 6702010 ; Catalog Number SBA53FFK11, UDI/DI 10197106494592 (EA)50197106494590 (CS), Lot Number 6928765 ; Catalog Number SBA53FFK12, UDI/DI 10197106655085 (EA)50197106655083 (CS), Lot Number 7331342 ; Catalog Number SBA53FFKH1, UDI/DI 10195594021399 (EA)50195594021397 (CS), Lot Number J9602T ; Catalog Number SBA53FFKH2, UDI/DI 10195594042035 (EA)50195594042033 (CS), Lot Number J8692W ; Catalog Number SBA53FFKH3, UDI/DI 10195594586843 (EA)50195594586841 (CS), Lot Number 5891309 ; Catalog Number SBA53FFKH4, UDI/DI 10195594813390 (EA)50195594813398 (CS), Lot Number 5891315 ; Catalog Number SBA53FFKH5, UDI/DI 10197106018569 (EA)50197106018567 (CS), Lot Number 6025791 ; Catalog Number SBA53FFKH6, UDI/DI 10197106041987 (EA)50197106041985 (CS), Lot Number 6264570 ; Catalog Number SBA53FFKH7, UDI/DI 10197106083475 (EA)50197106083473 (CS), Lot Number 6264569 ; Catalog Number SBA53FFKH8, UDI/DI 10197106180280 (EA)50197106180288 (CS), Lot Number 6560945 ; Catalog Number SBA53FFKH9, UDI/DI 10197106261156 (EA)50197106261154 (CS), Lot Number 6701852 ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J7963H ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J8123W ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J84K01 ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J8393W ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J8124A ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number PO170874 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number J8693A ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number N/A ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number J86T82 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number J9849F ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5136018 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5618932 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5631074 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5891312 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5970334 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 6025786 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332907 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332917 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 6596397 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 6928757 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 6928763 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7127056 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332904 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332914 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332916 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332905 ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number J8671M ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number J8692W ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number 5405626 ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number J6367F ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number 5664099 ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number 5876883 ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number 5891312 ; Catalog Number SBA5DFGUMC, UDI/DI 10197106675984 (EA)50197106675982 (CS), Lot Number 7332910 ; Catalog Number SBA5FSPMM5, UDI/DI 10195594918965 (EA)50195594918963 (CS), Lot Number J8671P ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J3464F ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J34J41 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J46C02 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J4952D ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J53W68 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J46C03 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J5679A ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J7704G ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J8064Y ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J86T81 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J9602T ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J6050H ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5140342 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5478803 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5664099 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5140345 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5664103 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5891312 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7127056 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7280109 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7331342 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7332910 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7332912 ; Catalog Number SBA60POLHB, UDI/DI 10197106730492 (EA)50197106730490 (CS), Lot Number 7332913 ; Catalog Number SBA60POLHB, UDI/DI 10197106730492 (EA)50197106730490 (CS), Lot Number 7332918 ; Catalog Number SBA73FFKO1, UDI/DI 10197106347904 (EA)50197106347902 (CS), Lot Number 6702012 ; Catalog Number SBA73FFKOA, UDI/DI 10197106288252 (EA)50197106288250 (CS), Lot Number 7163103 ; Catalog Number SBA73FFKOA, UDI/DI 10197106288252 (EA)50197106288250 (CS), Lot Number 6928771 ; Catalog Number SBA73FFKWB, UDI/DI 10197106744550 (EA)50197106744558 (CS), Lot Number 7332915 ; Catalog Number SBA73FFKWB, UDI/DI 10197106744550 (EA)50197106744558 (CS), Lot Number 7332908 ; Catalog Number SBAMHMFB10, UDI/DI 10195594132552 (EA)50195594132550 (CS), Lot Number J6050H ; Catalog Number SBAMHMFB11, UDI/DI 10195594249212 (EA)50195594249210 (CS), Lot Number 5140342 ; Catalog Number SBAMHMFB12, UDI/DI 10195594393137 (EA)50195594393135 (CS), Lot Number 5533333 ; Catalog Number SBAMHMFB13, UDI/DI 10195594520359 (EA)50195594520357 (CS), Lot Number 5140345 ; Catalog Number SBAMHMFB14, UDI/DI 10195594546144 (EA)50195594546142 (CS), Lot Number 5876883 ; Catalog Number SBAMHMFB15, UDI/DI 10197106118993 (EA)50197106118991 (CS), Lot Number 6560943 ; Catalog Number SBAMHMFB16, UDI/DI 10197106321577 (EA)50197106321575 (CS), Lot Number 6560946 ; Catalog Number SBAMHMFBH8, UDI/DI 10888439674149 (EA)50888439674147 (CS), Lot Number J4952C ; Catalog Number SBAMHMFBH9, UDI/DI 10195594055929 (EA)50195594055927 (CS), Lot Number J6367C ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J2977X ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J3987C ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J43U74 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J5679A ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J70X21 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J7704F ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number N/A ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J53W72 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J7905F ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J7963D ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J84K04 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J85W24 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J8671P ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J8692Z ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number 5631072 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 5891309 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 5891312 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 5891314 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6025786 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6025785 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 5631069 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6264565 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6025791 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6264569 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6563988 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 33NFHD ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6563990 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6022130 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6806113 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6914944 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6596397 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6914942 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6928758 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6928757 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7163033 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6928773 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7163082 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6928772 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7332911 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7332916 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7332908 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7332907 ; Catalog Number SEN11CMCP1, UDI/DI 10888439703269 (EA)50888439703267 (CS), Lot Number J53W67 ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J5679F ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J6050F ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J7963H ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J5679M ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J7905G ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J8393U ; Catalog Number SEN11CMCPB, UDI/DI 10888439941746 (EA)50888439941744 (CS), Lot Number J85W23 ; Catalog Number SEN11CMCPC, UDI/DI 10888439967500 (EA)50888439967508 (CS), Lot Number J8692Y ; Catalog Number SEN11CMCPC, UDI/DI 10888439967500 (EA)50888439967508 (CS), Lot Number J8693A ; Catalog Number SEN11ENN10, UDI/DI 10195594695897 (EA)50195594695895 (CS), Lot Number 6022064 ; Catalog Number SEN11ENN11, UDI/DI 10195594745288 (EA)50195594745286 (CS), Lot Number J6366P ; Catalog Number SEN11ENN12, UDI/DI 10195594780548 (EA)50195594780546 (CS), Lot Number 6279855 ; Catalog Number SEN11ENN13, UDI/DI 10195594845643 (EA)50195594845641 (CS), Lot Number 6345507 ; Catalog Number SEN11ENN14, UDI/DI 10197106019252 (EA)50197106019250 (CS), Lot Number 6487884 ; Catalog Number SEN11ENN15, UDI/DI 10197106239278 (EA)50197106239276 (CS), Lot Number 6775018 ; Catalog Number SEN11ENN16, UDI/DI 10197106321850 (EA)50197106321858 (CS), Lot Number 6701994 ; Catalog Number SEN11ENNY4, UDI/DI 10888439725339 (EA)50888439725337 (CS), Lot Number J53W33 ; Catalog Number SEN11ENNY5, UDI/DI 10195594086879 (EA)50195594086877 (CS), Lot Number 5138318 ; Catalog Number SEN11ENNY6, UDI/DI 10195594132033 (EA)50195594132031 (CS), Lot Number 5138317 ; Catalog Number SEN11ENNY7, UDI/DI 10195594216238 (EA)50195594216236 (CS), Lot Number J8670U ; Catalog Number SEN11ENNY8, UDI/DI 10195594322373 (EA)50195594322371 (CS), Lot Number J6366M ; Catalog Number SEN11ENNY9, UDI/DI 10195594375355 (EA)50195594375353 (CS), Lot Number 5138322 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J30T23 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J46A87 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J2649N ; Catalog Number SEN11ENNYQ, UDI/DI

Distribution pattern

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

device · product 2 of 10

Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;

Z-0909-2025
Recall number
Z-0909-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number SBAOCTEHH1, UDI/DI 10195594722685 (EA)50195594722683 (CS), Lot Number 21J2883 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18E1332 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18J2582 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18M3535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18M3535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19A0124 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19E1525 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19K3308 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number N/A ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19K3308 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19C0888 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19C0888 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19A0124 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19B0560 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SEN15SERM5, UDI/DI 10195594423469 (EA)50195594423467 (CS), Lot Number 5533336 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J3987C ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J43U74 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J46A98 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J46C04 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J72P53 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J8393W ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J6050H ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J86T82 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 5140356 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 5891304 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 6264567 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 6928759 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7163104 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7331342 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7332908 ;

Distribution pattern

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

device · product 3 of 10

Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6; 5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7

Z-0910-2025
Recall number
Z-0910-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J5678Z ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J6049R ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J53W78 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J74A27 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J7412G ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J6050A ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J8124C ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J8393C ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J7905J ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J6367G ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J9602R ; Catalog Number SCVHFAPBM6, UDI/DI 10195594031701 (EA)50195594031709 (CS), Lot Number J9602W ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number J6367C ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number 5136034 ; Catalog Number SCVHFAPBM7, UDI/DI 10195594127664 (EA)50195594127662 (CS), Lot Number J9850D ;

Distribution pattern

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

device · product 4 of 10

Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI

Z-0911-2025
Recall number
Z-0911-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J1896M ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J3987C ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J43U76 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J46C02 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J4952G ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J74A30 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J8064Z ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J8123Z ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J84K03 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 21K3110 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), Lot Number 21K3110 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 22D1239 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23F1430 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 23J2297 ; Catalog Number SENHDDPVCI, UDI/DI 10197106474570 (EA)50197106474578 (CS), Lot Number 24C0657 ;

Distribution pattern

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

device · product 5 of 10

Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH5 ; 5 ) STERILE LARYNGOSCOPY PACK, Catalog Number: SEN11LGUHB

Z-0912-2025
Recall number
Z-0912-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number SEN11LGUH2, UDI/DI 10195594093310 (EA)50195594093318 (CS), Lot Number J86T83 ; Catalog Number SEN11LGUH3, UDI/DI 10195594169626 (EA)50195594169624 (CS), Lot Number 5140349 ; Catalog Number SEN11LGUH4, UDI/DI 10195594230333 (EA)50195594230331 (CS), Lot Number 5405627 ; Catalog Number SEN11LGUH5, UDI/DI 10195594321871 (EA)50195594321879 (CS), Lot Number J6278U ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J43U76 ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J5679F ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J5679F ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J5679G ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J74A30 ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8064Z ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8123W ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8393U ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8692W ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J8671P ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number J86T83 ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number 5664098 ; Catalog Number SEN11LGUHB, UDI/DI 10887488360911 (EA)50887488360919 (CS), Lot Number 5631073 ;

Distribution pattern

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

device · product 6 of 10

Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLC; 5 ) KIT, EAR , Catalog Number: PE30EAGT6; 6 ) KIT, EAR , Catalog Number: PE30EAGT7; 7 ) KIT, EAR , Catalog Number: PE30EAGT8; 8 ) KIT, EAR , Catalog Number: PE30EAGT9; 9 ) KIT, EAR , Catalog Number: PE30EAGTB; 10 ) KIT, EAR , Catalog Number: PE30EAGTC; 11 ) KIT, EAR , Catalog Number: PE30EAGTD; 12 ) KIT, NASAL , Catalog Number: PE35NSB10; 13 ) KIT, NASAL , Catalog Number: PE35NSB11; 14 ) KIT, NASAL , Catalog Number: PE35NSB12; 15 ) KIT, NASAL , Catalog Number: PE35NSB13; 16 ) KIT, NASAL , Catalog Number: PE35NSB14; 17 ) KIT, NASAL , Catalog Number: PE35NSB15; 18 ) KIT, NASAL , Catalog Number: PE35NSB16; 19 ) KIT, NASAL , Catalog Number: PE35NSB17; 20 ) KIT, NASAL , Catalog Number: PE35NSB18; 21 ) KIT NASAL , Catalog Number: PE35NSB19; 22 ) KIT, NASAL , Catalog Number: PE35NSBL1; 23 ) KIT, NASAL , Catalog Number: PE35NSBL2; 24 ) KIT, NASAL , Catalog Number: PE35NSBL3; 25 ) KIT, NASAL , Catalog Number: PE35NSBL4; 26 ) KIT, NASAL , Catalog Number: PE35NSBL5; 27 ) KIT, NASAL , Catalog Number: PE35NSBL6; 28 ) KIT, NASAL , Catalog Number: PE35NSBL7; 29 ) KIT, NASAL , Catalog Number: PE35NSBL8; 30 ) KIT, NASAL , Catalog Number: PE35NSBL9; 31 ) KIT, NASAL , Catalog Number: PE35NSBLA; 32 ) KIT, NASAL , Catalog Number: PE35NSBLB; 33 ) KIT, NASAL , Catalog Number: PE35NSBLC; 34 ) KIT NASAL , Catalog Number: PE35NSBLD; 35 ) KIT, NASAL , Catalog Number: PE35NSBLF; 36 ) KIT, SINUS , Catalog Number: PE3ESKSG1; 37 ) KIT, SINUS , Catalog Number: PE3ESKSG2; 38 ) KIT, SINUS , Catalog Number: PE3ESKSGA; 39 ) KIT, SINUS , Catalog Number: PE3ESKSGB; 40 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU4; 41 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU5; 42 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU6; 43 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU7; 44 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUH; 45 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUI; 46 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNH3; 47 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNHE; 48 ) KIT,ORP MAJOR EAR , Catalog Number: PEHDMJVCG; 49 ) KIT,ENT, SW , Catalog Number: PEMHETMHA; 50 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH1; 51 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH2; 52 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHA; 53 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB10; 54 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB11; 55 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH4; 56 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH5; 57 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH6; 58 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH7; 59 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH8; 60 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH9; 61 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHP; 62 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHQ; 63 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHR; 64 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL011; 65 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL012; 66 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL01A; 67 ) KIT,NASAL SINUS ,PRESBYTERIAN , Catalog Number: PEV2CL102; 68 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL103; 69 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL104; 70 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL105; 71 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL106; 72 ) KIT,NASAL SINUS , PRESBYTERIAN , C

Z-0913-2025
Recall number
Z-0913-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 6928769 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7160527 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7163103 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7280105 ; Catalog Number PE23NSMEC, UDI/DI 10197106644829 (EA)50197106644827 (CS), Lot Number 7332911 ; Catalog Number PE23NSMEC, UDI/DI 10197106644829 (EA)50197106644827 (CS), Lot Number 7332915 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7160537 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7331341 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7332910 ; Catalog Number PE23SENLC, UDI/DI 10197106760956 (EA)50197106760954 (CS), Lot Number 7332917 ; Catalog Number PE30EAGT6, UDI/DI 10195594668167 (EA)50195594668165 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT7, UDI/DI 10195594725600 (EA)50195594725608 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT8, UDI/DI 10195594774950 (EA)50195594774958 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT9, UDI/DI 10197106038192 (EA)50197106038190 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 22D1239 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 22D1239 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19A0125 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19A0125 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 18J2583 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19B0516 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19L3475 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19E1526 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number XV2 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTC, UDI/DI 10197106667309 (EA)50197106667307 (CS), Lot Number 24C0657 ; Catalog Number PE30EAGTD, UDI/DI 10197106733622 (EA)50197106733620 (CS), Lot Number 22D1239 ; Catalog Number PE35NSB10, UDI/DI 10195594540302 (EA)50195594540300 (CS), Lot Number 5664101 ; Catalog Number PE35NSB11, UDI/DI 10195594565909 (EA)50195594565907 (CS), Lot Number 5891306 ; Catalog Number PE35NSB12, UDI/DI 10197106027165 (EA)50197106027163 (CS), Lot Number 6025791 ; Catalog Number PE35NSB13, UDI/DI 10197106236963 (EA)50197106236961 (CS), Lot Number 6596396 ; Catalog Number PE35NSB14, UDI/DI 10197106285398 (EA)50197106285396 (CS), Lot Number 6487901 ; Catalog Number PE35NSB15, UDI/DI 10197106310618 (EA)50197106310616 (CS), Lot Number 6563988 ; Catalog Number PE35NSB16, UDI/DI 10197106322390 (EA)50197106322398 (CS), Lot Number 6788560 ; Catalog Number PE35NSB17, UDI/DI 10197106365939 (EA)50197106365937 (CS), Lot Number 6806113 ; Catalog Number PE35NSB18, UDI/DI 10197106418710 (EA)50197106418718 (CS), Lot Number 6806115 ; Catalog Number PE35NSB19, UDI/DI 10197106702574 (EA)50197106702572 (CS), Lot Number 7332911 ; Catalog Number PE35NSBL1, UDI/DI 10888439745771 (EA)50888439745779 (CS), Lot Number J3464F ; Catalog Number PE35NSBL2, UDI/DI 10888439759099 (EA)50888439759097 (CS), Lot Number J1896M ; Catalog Number PE35NSBL3, UDI/DI 10195594038878 (EA)50195594038876 (CS), Lot Number J8124C ; Catalog Number PE35NSBL4, UDI/DI 10195594120542 (EA)50195594120540 (CS), Lot Number J6050H ; Catalog Number PE35NSBL5, UDI/DI 10195594268176 (EA)50195594268174 (CS), Lot Number 5405628 ; Catalog Number PE35NSBL6, UDI/DI 10195594400392 (EA)50195594400390 (CS), Lot Number 5533334 ; Catalog Number PE35NSBL7, UDI/DI 10195594424862 (EA)50195594424860 (CS), Lot Number 5533336 ; Catalog Number PE35NSBL8, UDI/DI 10195594454494 (EA)50195594454492 (CS), Lot Number J6278U ; Catalog Number PE35NSBL9, UDI/DI 10195594492496 (EA)50195594492494 (CS), Lot Number 5664102 ; Catalog Number PE35NSBLA, UDI/DI 10888439647693 (EA)50888439647691 (CS), Lot Number J4952G ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J53W68 ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J5679K ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J8064Z ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J84K01 ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J85W28 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6563989 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6914943 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6928764 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number J6050H ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891311 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891310 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5970334 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5631071 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891315 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6264565 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6345522 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7280105 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7280106 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7332906 ; Catalog Number PE35NSBLF, UDI/DI 10197106764299 (EA)50197106764297 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSG1, UDI/DI 10195594388850 (EA)50195594388858 (CS), Lot Number 5533333 ; Catalog Number PE3ESKSG2, UDI/DI 10195594885793 (EA)50195594885791 (CS), Lot Number J6278R ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6560946 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number J85H45 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5135984 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5664102 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5664101 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891308 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891310 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891312 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891313 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6025787 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6025788 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6264569 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6345523 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 24-04 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332916 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6701853 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6806113 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6914942 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6928758 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6928765 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7163033 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7163103 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7127056 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7287567 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7331341 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332910 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332915 ; Catalog Number PECGNAAU4, UDI/DI 10195594396022 (EA)50195594396020 (CS), Lot Number 5618932 ; Catalog Number PECGNAAU5, UDI/DI 10195594483487 (EA)50195594483485 (CS), Lot Number 5631074 ; Catalog Number PECGNAAU6, UDI/DI 10195594566210 (EA)50195594566218 (CS), Lot Number 5891306 ; Catalog Number PECGNAAU7, UDI/DI 10195594698812 (EA)50195594698810 (CS), Lot Number 5891313 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J3464F ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J43U74 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J31U57 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J46C02 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J4952C ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J34J42 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J5679K ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J7963G ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J84K03 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8671K ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number N/A ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8692Y ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8693A ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J86T83 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J85W23 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5140346 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5140342 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5664102 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5876883 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5891308 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7332916 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6560945 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6596397 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6914942 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6788562 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6788562 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928762 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928766 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928769 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928773 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7160537 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7163033 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928771 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928767 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7332904 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928770 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6025785 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 5631069 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6345521 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6345522 ; Catalog Number PEDHSPNH3, UDI/DI 10888439697575 (EA)50888439697573 (CS), Lot Number J4952D ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J43U74 ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J30T39 ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J4952G ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5678Z ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5679F ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5679M ; Catalog Number PEHDMJVCG, UDI/DI 10888439780963 (EA)50888439780961 (CS), Lot Number 19L3475 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6560944 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6701853 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6928757 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6928759 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7163033 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7280108 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7280109 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7287567 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332903 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332904 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332914 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332913 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5631073 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5891304 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5891315 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6264570 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6345522 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6560943 ; Catalog Number PEMHNFMH1, UDI/DI 10197106643495 (EA)50197106643493 (CS), Lot Number 7280109 ; Catalog Number PEMHNFMH2, UDI/DI 10197106679180 (EA)50197106679188 (CS), Lot Number 6914945 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6563989 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6928771 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5664101 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5891306 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5891307 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number J6367H ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6264565 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6264566 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6487901 ; Catalog Number PEMHNSB10, UDI/DI 10197106092972 (EA)50197106092970 (CS), Lot Number 6487902 ; Catalog Number PEMHNSB11, UDI/DI 10197106417195 (EA)50197106417193 (CS), Lot Number 6806115 ; Catalog Number PEMHNSBH4, UDI/DI 10888439572605 (EA)50888439572603 (CS), Lot Number J3464F ; Catalog Number PEMHNSBH5, UDI/DI 10888439581683 (EA)50888439581681 (CS), Lot Number J3464F ; Catalog Number PEMHNSBH6, UDI/DI 10195594950057 (EA)50195594950055 (CS), Lot Number J8693A ; Catalog Number PEMHNSBH7, UDI/DI 10195594244033 (EA)50195594244031 (CS), Lot Number 5140342 ; Catalog Number PEMHNSBH8, UDI/DI 10195594520809 (EA)50195594520807 (CS), Lot Number 5618933 ; Catalog Number PEMHNSBH9, UDI/DI 10195594563059 (EA)50195594563057 (CS), Lot Number 5664101 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J46A99 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J4952D ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J53W68 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J6050D ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8064Z ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8124C ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8671K ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8693A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number N/A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J9602T ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number N/A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5135984 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5618932 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5664098 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5747232 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5970333 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number J6278R ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5631071 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6025786 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number J6278R ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6264567 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6345522 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6560946 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6563990 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6702012 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6788561 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6928762 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7163033 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7163103 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7280106 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6914945 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7287567 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7332918 ; Catalog Number PEV2CL011, UDI/DI 10197106673539 (EA)50197106673537 (CS), Lot Number 7163082 ; Catalog Number PEV2CL012, UDI/DI 10197106730485 (EA)50197106730483 (CS), Lot Number 7332913 ; Catalog Number PEV2CL01A, UDI/DI 10197106651711 (EA)50197106651719 (CS), Lot Number 7332909 ; Catalog Number PEV2CL102, UDI/DI 10195594414245 (EA)50195594414243 (CS), Lot Number 5533336 ; Catalog Number PEV2CL103, UDI/DI 10195594680145 (EA)50195594680143 (CS), Lot Number 5891305 ; Catalog Number PEV2CL104, UDI/DI 10195594711849 (EA)50195594711847 (CS), Lot Number J6367H ; Catalog Number PEV2CL105, UDI/DI 10195594745806 (EA)50195594745804 (CS), Lot Number 1271519 ; Catalog Number PEV2CL105, UDI/DI 10195594745806 (EA)50195594745804 (CS), Lot Number 5631071 ; Catalog Number PEV2CL106, UDI/DI 10195594779818 (EA)50195594779816 (CS), Lot Number 6025788 ; Catalog Number PEV2CL107, UDI/DI 10195594824129 (EA)50195594824127 (CS), Lot Number 5664103 ; Catalog Number PEV2CL108, UDI/DI 10195594876166 (EA)50195594876164 (CS), Lot Number J6278R ; Catalog Number PEV2CL109, UDI/DI 10197106306628 (EA)50197106306626 (CS), Lot Number 6701853 ; Catalog Number PEV2CL10O, UDI/DI 10887488813486 (EA)50887488813484 (CS), Lot Number J46A97 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J43U74 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J43U77 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J4952G ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J53W72 ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J53W68 ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J7704F ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J8123W ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J8124A ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J6367G ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J6367G ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J86T82 ; Catalog Number PEV2CL10T, UDI/DI 10195594180713 (EA)50195594180711 (CS), Lot Number 5140355 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6563992 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number J1J0578Y ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5631074 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5631073 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891307 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891309 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891307 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6264568 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6345524 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6563988 ; Catalog Number PEV2CL10V, UDI/DI 10197106246979 (EA)50197106246977 (CS), Lot Number 6702009 ; Catalog Number PEV2CL10V, UDI/DI 10197106246979 (EA)50197106246977 (CS), Lot Number 6914942 ; Catalog Number PEV2CL10W, UDI/DI 10197106425794 (EA)50197106425792 (CS), Lot Number 6788562 ; Catalog Number PEV2CL10W, UDI/DI 10197106425794 (EA)50197106425792 (CS), Lot Number 6914943 ; Catalog Number PEV2CL10X, UDI/DI 10197106484326 (EA)50197106484324 (CS), Lot Number 6928765 ; Catalog Number PEV2CL10X, UDI/DI 10197106484326 (EA)50197106484324 (CS), Lot Number 7160537 ; Catalog Number PEV2CL10Z, UDI/DI 10197106546789 (EA)50197106546787 (CS), Lot Number 7280105 ; Catalog Number PEV2CL10Z, UDI/DI 10197106546789 (EA)50197106546787 (CS), Lot Number 6928767 ; Catalog Number PEV2FSNYA, UDI/DI 10197106516225 (EA)50197106516223 (CS), Lot Number 7163033 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7349689 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7127056 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7280110 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332903 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332910 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332916 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6022128 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6563990 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6345522 ; Catalog Number PEV2OT10G, UDI/DI 10197106245163 (EA)50197106245161 (CS), Lot Number 6914944 ; Catalog Number PEV2OT10G, UDI/DI 10197106245163 (EA)50197106245161 (CS), Lot Number 6914945 ; Catalog Number PEV2OT10H, UDI/DI 10197106484418 (EA)50197106484416 (CS), Lot Number 6928765 ; Catalog Number PEV2OT10H, UDI/DI 10197106484418 (EA)50197106484416 (CS), Lot Number 7160527 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7280108 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332917 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 6928771 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7280107 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 6928772 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7163082 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332913 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332917 ; Catalog Number PEX4SSMNA, UDI/DI 10197106242599 (EA)50197106242597 (CS), Lot Number 6022130 ; Catalog Number PG35NSBL1, UDI/DI 10888439569360 (EA)50888439569368 (CS), Lot Number J3464G ; Catalog Number PG35NSBLA, UDI/DI 10888439559729 (EA)50888439559727 (CS), Lot Number J3987D ; Catalog Number PG35NSBLA, UDI/DI 10888439559729 (EA)50888439559727 (CS), Lot Number J43U77 ; Catalog Number PNVMESCH8, UDI/DI 10195594436070 (EA)50195594436078 (CS), Lot Number J70X17 ; Catalog Number PNVMESCH8, UDI/DI 10195594436070 (EA)50195594436078 (CS), Lot Number 5138232 ; Catalog Number PNVMESCH9, UDI/DI 10195594457419 (EA)50195594457417 (CS), Lot Number J6278U ; Catalog Number PNVMESCH9, UDI/DI 10195594457419 (EA)50195594457417 (CS), Lot Number 5530911 ; Catalog Number PQMHETMH2, UDI/DI 10195594927462 (EA)50195594927460 (CS), Lot Number J86T81 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J3987C ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J43U74 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J43U77 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J22M99 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J4952G ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J53W72 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J5679F ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J74A30 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J7963H ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J8393W ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J85W28 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 20-1-3 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J9602T ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J86T82 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5405627 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5533336 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5140343 ; Catalog Number PQMHNFMH2, UDI/DI 10195594939335 (EA)50195594939333 (CS), Lot Number J86T82 ; Catalog Number PQMHNFMH3, UDI/DI 10195594033941 (EA)

Distribution pattern

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

device · product 7 of 10

Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8 6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9 7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR

Z-0914-2025
Recall number
Z-0914-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number PB11FSC10, UDI/DI 10197106452042 (EA)50197106452040 (CS), Lot Number 6928760 ; Catalog Number PB11FSCH5, UDI/DI 10195594665951 (EA)50195594665959 (CS), Lot Number 5891312 ; Catalog Number PB11FSCH6, UDI/DI 10195594760984 (EA)50195594760982 (CS), Lot Number 6022131 ; Catalog Number PB11FSCH7, UDI/DI 10195594788704 (EA)50195594788702 (CS), Lot Number 6025788 ; Catalog Number PB11FSCH8, UDI/DI 10197106000229 (EA)50197106000227 (CS), Lot Number J6278R ; Catalog Number PB11FSCH9, UDI/DI 10197106404751 (EA)50197106404759 (CS), Lot Number 6788562 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 7280109 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 6487904 ;

Distribution pattern

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

device · product 8 of 10

Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10) KIT, CRANIOTOMY PMH , Catalog Number: PN08CPPCA; 11) KIT, NEURO , Catalog Number: PN11NEXX1; 12) KIT, NEURO , Catalog Number: PN11NEXXA; 13) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW2; 14) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW3; 15) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWG; 16) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWH; 17) KIT, MAJOR NEURO , Catalog Number: PN21MNEG1; 18) KIT, MAJOR NEURO , Catalog Number: PN21MNEG2; 19) KIT, MAJOR NEURO , Catalog Number: PN21MNEG3; 20) KIT, MAJOR NEURO , Catalog Number: PN21MNEG4; 21) KIT, MAJOR NEURO , Catalog Number: PN21MNEG5; 22) KIT, MAJOR NEURO , Catalog Number: PN21MNEGA; 23) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26) KIT,CRANIOTOMY , Catalog Number: PN23CFAH2; 27) KIT,CRANIOTOMY , Catalog Number: PN23CFAH3; 28) KIT,CRANIOTOMY , Catalog Number: PN23CFAH4; 29) KIT,CRANIOTOMY , Catalog Number: PN23CFAH5; 30) KIT,CRANIOTOMY , Catalog Number: PN23CFAH6; 31) KIT,CRANIOTOMY , Catalog Number: PN23CFAH7; 32) KIT,CRANIOTOMY , Catalog Number: PN23CFAHA; 33) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY734; 37) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY735; 38) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73D; 40) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73F; 41) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73G; 42) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73H; 43) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46) KIT,CRANIOTOMY,ANDERSON , Catalog Number: PN23CYAMY; 47) KIT,LAMINECTOMY RF , Catalog Number: PN23LMCVU; 48) KIT, NEURO , Catalog Number: PN23NKME1; 49) KIT, NEURO , Catalog Number: PN23NKMEA; 50) KIT, NEURO , Catalog Number: PN23NKMEB; 51) KIT, NEURO , Catalog Number: PN23NKMEC; 52) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA10; 53) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA11; 54) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA12; 55) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA13; 56) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM3; 57) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM4; 58) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM6; 59) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM7; 60) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM8; 61) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM9; 62) NEURO SPINE,ANDERSON,KIT , Catalog Number: PN23SPAMS; 63) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMV; 64) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMW; 65) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMX; 66) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMY; 67) KIT, CRANIOTOMY , Catalog Number: PN29CRA10; 68) KIT, CRANIOTOMY , Catalog Number: PN29CRA11; 69) KIT, CR

Z-0915-2025
Recall number
Z-0915-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5631070 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5530905 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5138271 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5533340 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136018 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136034 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136012 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136019 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5140342 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5324034 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5138327 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5140378 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5478803 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5324048 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5138335 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5405629 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5478804 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5138222 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5138325 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5405629 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6701852 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6905475 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6748352 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6702036 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6788561 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6928764 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7163104 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331341 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6928772 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7332910 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J3464F ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J34J41 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37U06 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J43U77 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4952D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6050D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J74A27 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679M ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7963H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J8123Z ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J86T82 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631072 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631073 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5891310 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6025785 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6169297 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6345524 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6563988 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6907762 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6987090 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6806116 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7260066 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7163081 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7280113 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7260073 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7287536 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331351 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331283 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331323 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331347 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7287463 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7332858 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7269982 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7348991 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331474 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7280114 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4219A ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37T95 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J30T06 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4219D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J3986R ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37U14 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4678Z ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4219W ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37U14 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4679H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4877D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J332169 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J46C05 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4951F ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4877T ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4952R ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6049Y ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J65K13 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679P ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J68T51 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6786P ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679T ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J74A12 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J74A02 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679T ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J53W20 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J76N08 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7704J ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7962U ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J8045W ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7905H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J8491U ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J8064U ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7905J ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J84K06 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J70X14 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J70X08 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6368X ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631031 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5533309 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5533341 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631044 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631062 ; 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Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J46C04 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J53W73 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J72P53 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J74A28 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8064Y ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8064Z ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8123Z ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8393U ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J43U62 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J37U05 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J4950H ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J46A95 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J4951G ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J53W54 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J53W20 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J5678J ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J74A17 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J5678J ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J74A18 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J79H50 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J82M03 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J79H48 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J79H49 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J79H50 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8670H ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8393H ; Catalog Number PN08CPPCA, UDI/DI 10197106722909 (EA)50197106722907 (CS), Lot Number 7331310 ; Catalog Number PN11NEXX1, UDI/DI 10888439682618 (EA)50888439682616 (CS), Lot Number J46C04 ; Catalog Number PN11NEXX1, UDI/DI 10888439682618 (EA)50888439682616 (CS), Lot Number J4680A ; Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number J30T39 ; Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number J53W72 ; Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number J4949U ; Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number J53W13 ; Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number 18J2583 ; Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number J4952C ; Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number J4680A ; Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number J4952P ; Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number J6367F ; Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number 5138222 ; Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number 5533338 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number 18B0346 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J3464G ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number 19E1526 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J53W67 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J37T59 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J30T08 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J6277M ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J5679N ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 19L3475 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J5679H ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 19L3475 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J84K01 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 19L3475 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J84K02 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 5478803 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J82M01 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J7963U ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J82M01 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J7964A ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J8491U ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J85W30 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 5324047 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 5405629 ; Catalog Number PN21MNEG1, UDI/DI 10195594202040 (EA)50195594202048 (CS), Lot Number 5140356 ; Catalog Number PN21MNEG1, UDI/DI 10195594202040 (EA)50195594202048 (CS), Lot Number 5138244 ; Catalog Number PN21MNEG2, UDI/DI 10195594276119 (EA)50195594276117 (CS), Lot Number 5478803 ; Catalog Number PN21MNEG2, UDI/DI 10195594276119 (EA)50195594276117 (CS), Lot Number 5324034 ; Catalog Number PN21MNEG3, UDI/DI 10195594327347 (EA)50195594327345 (CS), Lot Number J6278U ; Catalog Number PN21MNEG3, UDI/DI 10195594327347 (EA)50195594327345 (CS), Lot Number 5324040 ; Catalog Number PN21MNEG4, UDI/DI 10195594725136 (EA)50195594725134 (CS), Lot Number 5970334 ; Catalog Number PN21MNEG4, UDI/DI 10195594725136 (EA)50195594725134 (CS), Lot Number 6022053 ; Catalog Number PN21MNEG5, UDI/DI 10195594767822 (EA)50195594767820 (CS), Lot Number 6025786 ; Catalog Number PN21MNEG5, UDI/DI 10195594767822 (EA)50195594767820 (CS), Lot Number 6022060 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6563989 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6563988 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6788561 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6928762 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6928766 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6928764 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7280110 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7287567 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7332904 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7332909 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6928772 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J8123Z ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J84K02 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J86T83 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5533336 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5618932 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J6278U ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5664100 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5876883 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5888374 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6022130 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6345523 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6264447 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6986974 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7122004 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7260053 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7286184 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7260068 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7280048 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7287483 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7331285 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7332804 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7332837 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J8393A ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J8491U ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J6366D ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5508039 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5530912 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 531025 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5508041 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J6277T ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6485589 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6687082 ; Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number 18H2278 ; Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number J46C03 ; Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number J5678M ; Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number 18M3535 ; Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number J6050D ; Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number J6365Y ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number 18H2205 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J37U06 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number 18H2278 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J46A97 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number 18H2278 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J22M99 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number 19A0124 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J4952M ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J3986K ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J4679C ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J4950G ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J53W13 ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J30T25 ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J3987C ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J4678K ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J4219Z ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J46A89 ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J37U13 ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J4219N ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J43U77 ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J4679P ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J43U77 ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J46A91 ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J46C06 ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J46A88 ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J46A98 ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J4680D ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J4951X ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J4952R ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J6366K ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number N/A ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J72P53 ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J72P50 ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J7498U ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J5679T ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number N/A ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J7498G ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J74A30 ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J7609N ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J6366T ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number N/A ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J74A38 ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J7498J ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J7704F ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J5678R ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J7704C ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J74A38 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J4951H ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number N/A ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J53W68 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J53W37 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J5679D ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J7904W ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J7963H ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J8064Z ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J84J95 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J7963D ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J85W16 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J8123Z ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number N/A ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J8670X ; Catalog Number PN23CFAHA, UD

Distribution pattern

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

device · product 9 of 10

Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE , Catalog Number: POHFSPMH1; 62) KIT, SPINE , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS

Z-0916-2025
Recall number
Z-0916-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J34J41 ; Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J43U77 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952G ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J53W73 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952H ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J6050F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J74A27 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7963D ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7905F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J84K02 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J8692Y ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J86T82 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 20166041-3014 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 5138318 ; Catalog Number PN33MSOC3, UDI/DI 10197106660881 (EA)50197106660889 (CS), Lot Number 7331471 ; Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number 7265882 ; Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number 7280085 ; Catalog Number PN33MSOCI, UDI/DI 10197106586525 (EA)50197106586523 (CS), Lot Number 7265980 ; Catalog Number PN40LMBY6, UDI/DI 10195594059576 (EA)50195594059574 (CS), Lot Number J9601U ; Catalog Number PN40LMBY6, UDI/DI 10195594059576 (EA)50195594059574 (CS), Lot Number J96A01 ; Catalog Number PN40LMBY7, UDI/DI 10195594163457 (EA)50195594163455 (CS), Lot Number J9601W ; Catalog Number PN40LMBY7, UDI/DI 10195594163457 (EA)50195594163455 (CS), Lot Number 5138235 ; Catalog Number PN40LMBY8, UDI/DI 10195594576653 (EA)50195594576651 (CS), Lot Number J70X03 ; Catalog Number PN40LMBY8, UDI/DI 10195594576653 (EA)50195594576651 (CS), Lot Number 5664035 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J30T23 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4951J ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J53W36 ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J7704A ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4678M ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J4949U ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J6049W ; Catalog Number PN40LMBYD, UDI/DI 10887488455440 (EA)50887488455448 (CS), Lot Number J79F27 ; Catalog Number PN40LMBYE, UDI/DI 10888439959642 (EA)50888439959640 (CS), Lot Number J7704A ; Catalog Number PN40LMBYE, UDI/DI 10888439959642 (EA)50888439959640 (CS), Lot Number J6786F ; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number BCS725327015001; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number 5138322 ; Catalog Number PN40LMBYF, UDI/DI 10195594239510 (EA)50195594239518 (CS), Lot Number 5530911 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332852 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6748343 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6701994 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6563921 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6806107 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6487885 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7265878 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7287503 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280085 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7331468 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7331303 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332852 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7102720 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6264449 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6986975 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7005435 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 6907766 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7122068 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7284052 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280047 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280048 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7287482 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7280050 ; Catalog Number PN40SPMMA, UDI/DI 10197106099384 (EA)50197106099382 (CS), Lot Number 7332804 ; Catalog Number PO40LMBY1, UDI/DI 10195594643676 (EA)50195594643674 (CS), Lot Number 5618930 ; Catalog Number PO40LMBY1, UDI/DI 10195594643676 (EA)50195594643674 (CS), Lot Number 5891287 ; Catalog Number PO40LMBY2, UDI/DI 10197106012901 (EA)50197106012909 (CS), Lot Number 6487884 ; Catalog Number PO40LMBY2, UDI/DI 10197106012901 (EA)50197106012909 (CS), Lot Number 6485582 ; Catalog Number PO40LMBY3, UDI/DI 10197106190494 (EA)50197106190492 (CS), Lot Number 6748342 ; Catalog Number PO40LMBY3, UDI/DI 10197106190494 (EA)50197106190492 (CS), Lot Number 6264449 ; Catalog Number PO40LMBY4, UDI/DI 10197106376102 (EA)50197106376100 (CS), Lot Number 6806107 ; Catalog Number PO40LMBY4, UDI/DI 10197106376102 (EA)50197106376100 (CS), Lot Number 6701970 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7110268 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7265878 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7122068 ; Catalog Number PO40LMBYC, UDI/DI 10197106375006 (EA)50197106375004 (CS), Lot Number 7287457 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7360338 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7332852 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701996 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6775018 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6806107 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265879 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7265977 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280085 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7331306 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7349669 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701995 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701994 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7045815 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280047 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701942 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7058621 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7005446 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7286183 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280044 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280044 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280059 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7280048 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7331284 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 7332832 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6701957 ; Catalog Number PO40OAMMA, UDI/DI 10197106099377 (EA)50197106099375 (CS), Lot Number 6568661 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6563990 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6487901 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6914944 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928766 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928764 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7127056 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7160537 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928773 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7163104 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7280110 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7280109 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928772 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 7332910 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 2407826964 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6928770 ; Catalog Number PO4ASPWMA, UDI/DI 10197106045435 (EA)50197106045433 (CS), Lot Number 6345524 ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4951J ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4949R ; Catalog Number POHDAS951, UDI/DI 10888439654523 (EA)50888439654521 (CS), Lot Number J4877G ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J79H44 ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J7904N ; Catalog Number POHDAS952, UDI/DI 10888439893762 (EA)50888439893760 (CS), Lot Number J8064U ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number 5775791 ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number J6049X ; Catalog Number POHDAS953, UDI/DI 10195594565527 (EA)50195594565525 (CS), Lot Number 5664045 ; Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number 6279851 ; Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number 6264450 ; Catalog Number POHDAS954, UDI/DI 10195594785086 (EA)50195594785084 (CS), Lot Number 6345509 ; Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number 6345507 ; Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number 6485580 ; Catalog Number POHDAS955, UDI/DI 10195594889913 (EA)50195594889911 (CS), Lot Number 6364783 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J7498G ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J84J96 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J7704A ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J7609N ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J76N06 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J89H91 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J89C53 ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J6785Z ; Catalog Number POHDAS95F, UDI/DI 10888439797459 (EA)50888439797457 (CS), Lot Number J70X09 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J8670W ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J86Y70 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J9601U ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J68T47 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J86N64 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J6910U ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J70X08 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J96N37 ; Catalog Number POHDAS95G, UDI/DI 10888439987713 (EA)50888439987711 (CS), Lot Number J9699Z ; Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number 5631051 ; Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number 5631025 ; Catalog Number POHDAS95J, UDI/DI 10195594440961 (EA)50195594440969 (CS), Lot Number 5533325 ; Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number H2357570 ; Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number 5918336 ; Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number 6701849 ; Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number 5891283 ; Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number 5775800 ; Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number 6687065 ; Catalog Number POHDAS95K, UDI/DI 10195594612979 (EA)50195594612977 (CS), Lot Number 6470285 ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J30T19 ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J30T21 ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J2649N ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J43U69 ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J4951J ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J4951N ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J4219A ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J3986R ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J3986T ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J4678U ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number N/A ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J43U72 ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J4950G ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J4877G ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J4877H ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J53W13 ; Catalog Number POHDFSVCD, UDI/DI 10888439532111 (EA)50888439532119 (CS), Lot Number J46A80 ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J7498G ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J7703Y ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J8393F ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J8123D ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J74A18 ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J74A02 ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J79F30 ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J8045W ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J8392Y ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J8123J ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J6786C ; Catalog Number POHDFSVCE, UDI/DI 10888439749786 (EA)50888439749784 (CS), Lot Number J86N64 ; Catalog Number POHDOSWC1, UDI/DI 10197106017586 (EA)50197106017584 (CS), Lot Number 6487884 ; Catalog Number POHDOSWC1, UDI/DI 10197106017586 (EA)50197106017584 (CS), Lot Number 6563795 ; Catalog Number POHDOSWC2, UDI/DI 10197106157800 (EA)50197106157808 (CS), Lot Number 6748342 ; Catalog Number POHDOSWC2, UDI/DI 10197106157800 (EA)50197106157808 (CS), Lot Number 6701966 ; Catalog Number POHDOSWC3, UDI/DI 10197106342367 (EA)50197106342365 (CS), Lot Number 6987085 ; Catalog Number POHDOSWC3, UDI/DI 10197106342367 (EA)50197106342365 (CS), Lot Number 7005445 ; Catalog Number POHDOSWC4, UDI/DI 10197106414989 (EA)50197106414987 (CS), Lot Number 7005460 ; Catalog Number POHDOSWC4, UDI/DI 10197106414989 (EA)50197106414987 (CS), Lot Number 7055825 ; Catalog Number POHDOSWC5, UDI/DI 10197106485637 (EA)50197106485635 (CS), Lot Number 7110268 ; Catalog Number POHDOSWC5, UDI/DI 10197106485637 (EA)50197106485635 (CS), Lot Number 7280114 ; Catalog Number POHDOSWC6, UDI/DI 10197106497814 (EA)50197106497812 (CS), Lot Number 7265882 ; Catalog Number POHDOSWC6, UDI/DI 10197106497814 (EA)50197106497812 (CS), Lot Number 7286184 ; Catalog Number POHDOSWC7, UDI/DI 10197106559611 (EA)50197106559619 (CS), Lot Number 7265884 ; Catalog Number POHDOSWC7, UDI/DI 10197106559611 (EA)50197106559619 (CS), Lot Number 7280056 ; Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number 6775015 ; Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number 7265882 ; Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number 7265883 ; Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number 6905475 ; Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number 7160480 ; Catalog Number POHDOSWCB, UDI/DI 10195594835484 (EA)50195594835482 (CS), Lot Number 7280036 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7332852 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7265883 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7287505 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7331468 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7332854 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7331306 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7332854 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7349669 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7102719 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7280044 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7287460 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7287481 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7332803 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 7332806 ; Catalog Number POHDOSWCC, UDI/DI 10197106495032 (EA)50197106495030 (CS), Lot Number 6560925 ; Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number 5565992 ; Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number 5405612 ; Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number 5405617 ; Catalog Number POHDPSV10, UDI/DI 10195594385347 (EA)50195594385345 (CS), Lot Number 5508060 ; Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number 5138323 ; Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number 5631028 ; Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number 5533307 ; Catalog Number POHDPSV11, UDI/DI 10195594455552 (EA)50195594455550 (CS), Lot Number 5478805 ; Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number J65K10 ; Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number 5664019 ; Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number 5508054 ; Catalog Number POHDPSV12, UDI/DI 10195594535469 (EA)50195594535467 (CS), Lot Number 5664107 ; Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number 5775791 ; Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number J6049X ; Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number 5508051 ; Catalog Number POHDPSV13, UDI/DI 10195594562328 (EA)50195594562326 (CS), Lot Number 5664107 ; Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number 6279851 ; Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number 6025760 ; Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number 6232007 ; Catalog Number POHDPSV14, UDI/DI 10195594762384 (EA)50195594762382 (CS), Lot Number 6133661 ; Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number 6169295 ; Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number 6345500 ; Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number 6022071 ; Catalog Number POHDPSV15, UDI/DI 10195594799816 (EA)50195594799814 (CS), Lot Number 6264574 ; Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number 6411419 ; Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number 6485577 ; Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number 6345510 ; Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number 202109016-KSH ; Catalog Number POHDPSV16, UDI/DI 10195594888947 (EA)50195594888945 (CS), Lot Number 6345526 ; Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number 6487889 ; Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number 6560930 ; Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number 6498134 ; Catalog Number POHDPSV17, UDI/DI 10197106037171 (EA)50197106037179 (CS), Lot Number 6345527 ; Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number 6487888 ; Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number 6025767 ; Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number 6470296 ; Catalog Number POHDPSV18, UDI/DI 10197106121405 (EA)50197106121403 (CS), Lot Number 6702023 ; Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number J4219N ; Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number J37T60 ; Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number J4219T ; Catalog Number POHDPSVC3, UDI/DI 10888439601855 (EA)50888439601853 (CS), Lot Number J37U15 ; Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number J4951H ; Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number J53W05 ; Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number J4877M ; Catalog Number POHDPSVC4, UDI/DI 10888439689020 (EA)50888439689028 (CS), Lot Number J4952U ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number J5677Z ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number N/A ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number J6049T ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number J6278J ; Catalog Number POHDPSVC5, UDI/DI 10888439793475 (EA)50888439793473 (CS), Lot Number J43U79 ; Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number J5678C ; Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number J76N04 ; Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number J7904X ; Catalog Number POHDPSVC6, UDI/DI 10888439855814 (EA)50888439855812 (CS), Lot Number J76D61 ; Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number J79H47 ; Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number J82K98 ; Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number J8064U ; Catalog Number POHDPSVC7, UDI/DI 10888439901894 (EA)50888439901892 (CS), Lot Number J7963X ; Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number J84J96 ; Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number 5136036 ; Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number 5136012 ; Catalog Number POHDPSVC8, UDI/DI 10195594128708 (EA)50195594128706 (CS), Lot Number J9850D ; Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number J6278F ; Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number 5311244 ; Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number 5138330 ; Catalog Number POHDPSVC9, UDI/DI 10195594243371 (EA)50195594243379 (CS), Lot Number 5140378 ; Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number J8393F ; Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number J8670J ; Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number J86N65 ; Catalog Number POHDPSVCI, UDI/DI 10888439938531 (EA)50888439938539 (CS), Lot Number J85W31 ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J84J96 ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J8670Z ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J6910P ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J70X09 ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J9424H ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J6368Z ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J96N36 ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J9424M ; Catalog Number POHDPSVCJ, UDI/DI 10888439985955 (EA)50888439985953 (CS), Lot Number J6368U ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number J9601W ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number 5405610 ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number 5508050 ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number 5508060 ; Catalog Number POHDPSVCK, UDI/DI 10195594382957 (EA)50195594382955 (CS), Lot Number 5533338 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 5775794 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 6487884 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 5664021 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 5891301 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 5970335 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 6563795 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 6416684 ; Catalog Number POHDPSVCM, UDI/DI 10195594612986 (EA)50195594612984 (CS), Lot Number 6487906 ; Catalog Number POHFSPMH1, UDI/DI 10888439747515 (EA)

Distribution pattern

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

device · product 10 of 10

Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH4; 6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5; 7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6; 8) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHA; 9) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHB; 10) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHC; 11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD; 12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE; 13) ENT PACK , Catalog Number: SEN55ENSH2; 14) ENT PACK , Catalog Number: SEN55ENSHA; 15) ENT PACK , Catalog Number: SEN55ENSHB; 16) EYE PACK , Catalog Number: SEY51EYKIK; 17) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH1; 18) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH2; 19) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHB; 20) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHC;;

Z-0917-2025
Recall number
Z-0917-2025
Initiated
November 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
512,786 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential 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

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number J43U76 ; Catalog Number PEHFHNAMHJ, UDI/DI 10888439038620 (EA)50888439038628 (CS), Lot Number J43U77 ; Catalog Number PWHFHNAMH1, UDI/DI 10888439744729 (EA)50888439744727 (CS), Lot Number J34J42 ; Catalog Number PWHFHNAMH2, UDI/DI 10195594014018 (EA)50195594014016 (CS), Lot Number J8124C ; Catalog Number PWHFHNAMH3, UDI/DI 10195594343477 (EA)50195594343475 (CS), Lot Number 5478802 ; Catalog Number PWHFHNAMH4, UDI/DI 10197106340523 (EA)50197106340521 (CS), Lot Number 6702010 ; Catalog Number PWHFHNAMH5, UDI/DI 10197106497425 (EA)50197106497423 (CS), Lot Number 6928766 ; Catalog Number PWHFHNAMH6, UDI/DI 10197106566107 (EA)50197106566105 (CS), Lot Number 7280108 ; Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number J53W73 ; Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number J5679J ; Catalog Number PWHFHNAMHA, UDI/DI 10888439654813 (EA)50888439654811 (CS), Lot Number J5679D ; Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number J6050D ; Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number J5679K ; Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number J5679K ; Catalog Number PWHFHNAMHB, UDI/DI 10888439828900 (EA)50888439828908 (CS), Lot Number J74A31 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 6596396 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number J8671P ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number J6050H ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5135997 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5533333 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number J70X17 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5664099 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5140345 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5664103 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5891308 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 5891307 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number J6367H ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 6025791 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number L00302 ; Catalog Number PWHFHNAMHC, UDI/DI 10888439993639 (EA)50888439993637 (CS), Lot Number 6560945 ; Catalog Number PWHFHNAMHD, UDI/DI 10197106344972 (EA)50197106344970 (CS), Lot Number 6702009 ; Catalog Number PWHFHNAMHE, UDI/DI 10197106644010 (EA)50197106644018 (CS), Lot Number 6928770 ; Catalog Number SEN55ENSH2, UDI/DI 10197106366837 (EA)50197106366835 (CS), Lot Number 6914944 ; Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number 6022130 ; Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number 6702009 ; Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number 6806115 ; Catalog Number SEN55ENSHA, UDI/DI 10197106141540 (EA)50197106141548 (CS), Lot Number 6806114 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 6928759 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 6928766 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7280107 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 5 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7280109 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7331341 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7332916 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 6928772 ; Catalog Number SEN55ENSHB, UDI/DI 10197106431429 (EA)50197106431427 (CS), Lot Number 7332907 ; Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number 7332905 ; Catalog Number SEY51EYKIK, UDI/DI 10197106741597 (EA)50197106741595 (CS), Lot Number 6928770 ; Catalog Number SEYOCPEHH1, UDI/DI 10888439980271 (EA)50888439980279 (CS), Lot Number J8692Y ; Catalog Number SEYOCPEHH2, UDI/DI 10197106337004 (EA)50197106337002 (CS), Lot Number 6702010 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J37U06 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J31U58 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J46C00 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J4952D ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J5679A ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J53W68 ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number N/A ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J5679K ; Catalog Number SEYOCPEHHB, UDI/DI 10888439551716 (EA)50888439551714 (CS), Lot Number J84K02 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 2300125464 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6563992 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6702010 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6928758 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6928759 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6928764 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 7163103 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 7280105 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 7332904 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6928770 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 7332918 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number J86T81 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5135984 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5140348 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5405626 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5533334 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5664098 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5747232 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5891307 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5891305 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 5891313 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6022133 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6022130 ; Catalog Number SEYOCPEHHC, UDI/DI 10195594914998 (EA)50195594914996 (CS), Lot Number 6264567 ;

Distribution pattern

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