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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94763

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

Open FDA event record

Event summary

Timeline bucket
May 29, 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

4 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 4

Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS609; 6) STERILE ANGIOGRAPHY PACK, Catalog Number SAN13BS60K; 7) ANGIOGRAPHY PACK, Catalog Number SAN13BS60L; 8) ANGIOGRAPHY PACK, Catalog Number SAN13BS60M; 9) ANGIOGRAPHY PACK, Catalog Number SAN13BS60N; 10) ANGIOGRAPHY PACK, Catalog Number SAN13BS60O; 11) CATH LAB PACK, Catalog Number SAN13CLET2; 12) CATH LAB PACK, Catalog Number SAN13CLETC; 13) CATH LAB PACK, Catalog Number SAN13CLETD; 14) ARTERIOGRAM PACK, Catalog Number SAN21AGE10; 15) ARTERIOGRAM PACK, Catalog Number SAN21AGEG6; 16) ARTERIOGRAM PACK, Catalog Number SAN21AGEG7; 17) ARTERIOGRAM PACK, Catalog Number SAN21AGEG8; 18) ARTERIOGRAM PACK, Catalog Number SAN21AGEG9; 19) ARTERIOGRAM PACK, Catalog Number SAN21AGEGJ; 20) ARTERIOGRAM PACK, Catalog Number SAN21AGEGK; 21) ARTERIOGRAM PACK, Catalog Number SAN21AGEGL; 22) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ10; 23) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ11; 24) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ12; 25) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ13; 26) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ14; 27) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ15; 28) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ16; 29) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ17; 30) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ18; 31) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ19; 32) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC6; 33) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC7; 34) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC8; 35) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC9; 36) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJCH; 37) CVL PACK, Catalog Number SAN22CVW12; 38) CVL PACK, Catalog Number SAN22CVW14; 39) CVL PACK, Catalog Number SAN22CVW15; 40) CVL PACK, Catalog Number SAN22CVW16; 41) CVL PACK, Catalog Number SAN22CVW17; 42) CVL PACK, Catalog Number SAN22CVW18; 43) CVL PACK, Catalog Number SAN22CVW19; 44) CVL PACK, Catalog Number SAN22CVW20; 45) CVL PACK, Catalog Number SAN22CVWRK; 46) CVL PACK, Catalog Number SAN22CVWRL; 47) ACCESSORY PACK, Catalog Number SAN37ASMO3; 48) ACCESSORY PACK, Catalog Number SAN37ASMO4; 49) ACCESSORY PACK, Catalog Number SAN37ASMO5; 50) ACCESSORY PACK, Catalog Number SAN37ASMOE; 51) ACCESSORY PACK, Catalog Number SAN37ASMOF; 52) ACCESSORY PACK, Catalog Number SAN37ASMOG; 53) ACCESSORY PACK, Catalog Number SAN37ASMOH; 54) PEDIATRIC CARDIAC CATH PACK, Catalog Number SAN57PD00K; 55) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS10; 56) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS11; 57) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSM7; 58) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM8; 59) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM9; 60) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSMK; 61) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSML; 62) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSMN; 63) CATH PACK, Catalog Number SAN73CHS10; 64) CATH PACK, Catalog Number SAN73CHS11; 65) CATH PACK, Catalog Number SAN73CHSJ5; 66) CATH PACK, Catalog Number SAN73CHSJ6; 67) CATH PACK, Catalog Number SAN73CHSJ7; 68) CATH PACK, Catalog Number SAN73CHSJ8; 69) CATH PACK, Catalog Number SAN73CHSJ9; 70) CATH PACK, Catalog Number SAN73CHSJJ; 71) CATH PACK, Catalog Number SAN73CHSJK; 72) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSB; 73) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSC; 74) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGR4; 75) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRJ; 76) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRK; 77) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA13; 78) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA14; 79) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA15; 80) ANGIOGRAPHY DRAPE PACK CMC,

Z-2327-2024
Recall number
Z-2327-2024
Initiated
May 29, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
136753 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

Code information

1) SAN13BS605, UDI/DI (CS/EA) 50888439661574/10888439661576, Lot Numbers: 358969; 2) SAN13BS606, UDI/DI (CS/EA) 50195594317339/10195594317331, Lot Numbers: 683419; 3) SAN13BS607, UDI/DI (CS/EA) 50195594746986/10195594746988, Lot Numbers: 866520; 4) SAN13BS608, UDI/DI (CS/EA) 50195594778772/10195594778774, Lot Numbers: 887311; 5) SAN13BS609, UDI/DI (CS/EA) 50197106253227/10197106253229, Lot Numbers: 39241; 6) SAN13BS60K, UDI/DI (CS/EA) 50887488801436/10887488801438, Lot Numbers: 229810, 262632, 276480, 297564; 7) SAN13BS60L, UDI/DI (CS/EA) 50888439596357/10888439596359, Lot Numbers: 317663, 375743, 413389, 430039, 456790, 480663, 505742, 530846, 555938, 578665, 608032, 616691, 636514, 660643, 689306; 8) SAN13BS60M, UDI/DI (CS/EA) 50195594473073/10195594473075, Lot Numbers: 750483, 766968, 785075; 9) SAN13BS60N, UDI/DI (CS/EA) 50195594635730/10195594635732, Lot Numbers: 814888, 832379, 893931; 10) SAN13BS60O, UDI/DI (CS/EA) 50195594796813/10195594796815, Lot Numbers: 14519, 55994, 72799, 82775, 89384, 111731, 114055, 131433, 156021, 177997, 213162, 264000, 911967, 930128, 950922, 971740, 991212; 11) SAN13CLET2, UDI/DI (CS/EA) 50197106250646/10197106250648, Lot Numbers: 36883; 12) SAN13CLETC, UDI/DI (CS/EA) 50888439268834/10888439268836, Lot Numbers: 230539, 246895, 287853, 327203, 347971, 369115, 410044, 436785, 465770, 485295, 497198, 509738, 546865, 568745; 13) SAN13CLETD, UDI/DI (CS/EA) 50195594942180/10195594942182, Lot Numbers: 10433, 41607, 68974, 111579, 111828, 120719, 132413, 140179, 187403, 195808, 247166, 267724, 280164, 606687, 636751, 664029, 688523, 714600, 735582, 770617, 803844, 827746, 845899, 861463, 890708, 894367, 906005, 923315, 944987, 952212, 989195; 14) SAN21AGE10, UDI/DI (CS/EA) 50197106258901/10197106258903, Lot Numbers: 40930; 15) SAN21AGEG6, UDI/DI (CS/EA) 50195594092663/10195594092665, Lot Numbers: 619968; 16) SAN21AGEG7, UDI/DI (CS/EA) 50195594489784/10195594489786, Lot Numbers: 743830; 17) SAN21AGEG8, UDI/DI (CS/EA) 50195594524362/10195594524364, Lot Numbers: 760050; 18) SAN21AGEG9, UDI/DI (CS/EA) 50197106068760/10197106068762, Lot Numbers: 958044; 19) SAN21AGEGJ, UDI/DI (CS/EA) 50195594004093/10195594004095, Lot Numbers: 653986, 666654, 702552, 767979, 806380, 817797, 831491, 848171, 870905, 888329, 908189, 925092; 20) SAN21AGEGK, UDI/DI (CS/EA) 50197106074945/10197106074947, Lot Numbers: 16107, 62787, 95786, 123784, 123815, 143550, 170317, 969373, 982319, 998196; 21) SAN21AGEGL, UDI/DI (CS/EA) 50197106455522/10197106455524, Lot Numbers: 227400, 248353, 259022, 277966; 22) SAN21NAJ10, UDI/DI (CS/EA) 50195594610515/10195594610517, Lot Numbers: 803145; 23) SAN21NAJ11, UDI/DI (CS/EA) 50195594669612/10195594669614, Lot Numbers: 826839; 24) SAN21NAJ12, UDI/DI (CS/EA) 50195594787071/10195594787073, Lot Numbers: 890454; 25) SAN21NAJ13, UDI/DI (CS/EA) 50195594870766/10195594870768, Lot Numbers: 915174; 26) SAN21NAJ14, UDI/DI (CS/EA) 50197106037780/10197106037782, Lot Numbers: 941597; 27) SAN21NAJ15, UDI/DI (CS/EA) 50197106108060/10197106108062, Lot Numbers: 972928; 28) SAN21NAJ16, UDI/DI (CS/EA) 50197106136353/10197106136355, Lot Numbers: 987075; 29) SAN21NAJ17, UDI/DI (CS/EA) 50197106289943/10197106289945, Lot Numbers: 50947; 30) SAN21NAJ18, UDI/DI (CS/EA) 50197106327300/10197106327302, Lot Numbers: 66821; 31) SAN21NAJ19, UDI/DI (CS/EA) 50197106410590/10197106410592, Lot Numbers: 107016; 32) SAN21NAJC6, UDI/DI (CS/EA) 50195594214058/10195594214050, Lot Numbers: 650449; 33) SAN21NAJC7, UDI/DI (CS/EA) 50195594323309/10195594323301, Lot Numbers: 683284; 34) SAN21NAJC8, UDI/DI (CS/EA) 50195594503442/10195594503444, Lot Numbers: 748742; 35) SAN21NAJC9, UDI/DI (CS/EA) 50195594525444/10195594525446, Lot Numbers: 759388; 36) SAN21NAJCH, UDI/DI (CS/EA) 50195594957849/10195594957841, Lot Numbers: 130141, 225181, 227211, 252404; 37) SAN22CVW12, UDI/DI (CS/EA) 50195594859396/10195594859398, Lot Numbers: 914634; 38) SAN22CVW14, UDI/DI (CS/EA) 50197106118496/10197106118498, Lot Numbers: 979530; 39) SAN22CVW15, UDI/DI (CS/EA) 50197106292387/10197106292389, Lot Numbers: 54624; 40) SAN22CVW16, UDI/DI (CS/EA) 50197106378166/10197106378168, Lot Numbers: 91797; 41) SAN22CVW17, UDI/DI (CS/EA) 50197106380855/10197106380857, Lot Numbers: 93517; 42) SAN22CVW18, UDI/DI (CS/EA) 50197106420070/10197106420072, Lot Numbers: 113807; 43) SAN22CVW19, UDI/DI (CS/EA) 50197106446056/10197106446058, Lot Numbers: 129896; 44) SAN22CVW20, UDI/DI (CS/EA) 50197106520855/10197106520857, Lot Numbers: 186939; 45) SAN22CVWRK, UDI/DI (CS/EA) 50195594611581/10195594611583, Lot Numbers: 5852, 23902, 41861, 140670, 154227, 172485, 927707, 958373, 989749, 996690; 46) SAN22CVWRL, UDI/DI (CS/EA) 50197106563401/10197106563403, Lot Numbers: 221129, 236549; 47) SAN37ASMO3, UDI/DI (CS/EA) 50195594456694/10195594456696, Lot Numbers: 728175; 48) SAN37ASMO4, UDI/DI (CS/EA) 50195594649461/10195594649463, Lot Numbers: 817180; 49) SAN37ASMO5, UDI/DI (CS/EA) 50195594678058/10195594678050, Lot Numbers: 834017; 50) SAN37ASMOE, UDI/DI (CS/EA) 50888439271858/10888439271850, Lot Numbers: 231050, 272697, 304203, 337561, 361334, 374047, 404273; 51) SAN37ASMOF, UDI/DI (CS/EA) 50888439794678/10888439794670, Lot Numbers: 425986, 451839, 472968, 491554, 538007, 571527, 595688, 633448, 653939, 675666, 697430, 760614, 791123, 851651, 876985, 913881, 936605, 957258, 979334; 52) SAN37ASMOG, UDI/DI (CS/EA) 50197106122981/10197106122983, Lot Numbers: 3807, 28744, 48028, 72836; 53) SAN37ASMOH, UDI/DI (CS/EA) 50197106350902/10197106350904, Lot Numbers: 96874, 129504, 166973, 184309, 203792, 218690, 228918, 246193, 268437; 54) SAN57PD00K, UDI/DI (CS/EA) 50195594793058/10195594793050, Lot Numbers: 25504, 42250, 84745, 107010, 121665, 145947, 156920; 55) SAN5BCLS10, UDI/DI (CS/EA) 50195594434791/10195594434793, Lot Numbers: 721166; 56) SAN5BCLS11, UDI/DI (CS/EA) 50195594485557/10195594485559, Lot Numbers: 741232; 57) SAN5BCLSM7, UDI/DI (CS/EA) 50888439669761/10888439669763, Lot Numbers: 366522; 58) SAN5BCLSM8, UDI/DI (CS/EA) 50195594202642/10195594202644, Lot Numbers: 648983; 59) SAN5BCLSM9, UDI/DI (CS/EA) 50195594382566/10195594382568, Lot Numbers: 698988; 60) SAN5BCLSMK, UDI/DI (CS/EA) 50888439230329/10888439230321, Lot Numbers: 231983, 254781, 283063, 299671, 334750, 344689, 403812, 418589, 431114, 444005, 491105, 502065, 513154, 534399, 559861; 61) SAN5BCLSML, UDI/DI (CS/EA) 50195594931320/10195594931322, Lot Numbers: 581440; 62) SAN5BCLSMN, UDI/DI (CS/EA) 50195594064844/10195594064846, Lot Numbers: 628969, 630087, 677383, 769024, 790249, 821783, 836924, 863422, 876889, 916451, 929050, 960172, 970962, 970984, 990675, 996059; 63) SAN73CHS10, UDI/DI (CS/EA) 50197106011483/ 0197106011485, Lot Numbers: 928873; 64) SAN73CHS11, UDI/DI (CS/EA) 50197106234134/10197106234136, Lot Numbers: 33743; 65) SAN73CHSJ5, UDI/DI (CS/EA) 50195594414946/10195594414948, Lot Numbers: 713075; 66) SAN73CHSJ6, UDI/DI (CS/EA) 50197106021987/10197106021989, Lot Numbers: 934300; 67) SAN73CHSJ7, UDI/DI (CS/EA) 50195594522757/10195594522759, Lot Numbers: 758996; 68) SAN73CHSJ8, UDI/DI (CS/EA) 50195594822321/10195594822323, Lot Numbers: 904557; 69) SAN73CHSJ9, UDI/DI (CS/EA) 50195594898616/10195594898618, Lot Numbers: 924563; 70) SAN73CHSJJ, UDI/DI (CS/EA) 50888439989500/10888439989502, Lot Numbers: 600640, 631948, 643749, 673661, 783542, 810742, 835551, 849558, 871180, 894682, 942716, 958087, 967193; 71) SAN73CHSJK, UDI/DI (CS/EA) 50197106105526/10197106105528, Lot Numbers: 6595, 43048, 80329, 94861, 106286, 119205, 133307, 150774, 161644, 182516, 219131, 254189, 264478, 280219, 982435, 997043; 72) SAN7AAPHSB, UDI/DI (CS/EA) 50195594057112/10195594057114, Lot Numbers: 748698, 803052; 73) SAN7AAPHSC, UDI/DI (CS/EA) 50195594420916/10195594420918, Lot Numbers: 7199, 14110, 43508, 45954, 67278, 95220, 191372, 213611, 247815, 826776, 835862, 840520, 974661; 74) SAN7CAGGR4, UDI/DI (CS/EA) 50195594526373/10195594526375, Lot Numbers: 760019; 75) SAN7CAGGRJ, UDI/DI (CS/EA) 50195594094339/10195594094331, Lot Numbers: 728464, 764589, 779672, 850059; 76) SAN7CAGGRK, UDI/DI (CS/EA) 50195594714558/10195594714550, Lot Numbers: 26767, 112526, 254843, 917521, 941243, 954047; 77) SANCGADA13, UDI/DI (CS/EA) 50197106311538/10197106311530, Lot Numbers: 506693; 78) SANCGADA14, UDI/DI (CS/EA) 50197106382620/10197106382622, Lot Numbers: 507442; 79) SANCGADA15, UDI/DI (CS/EA) 50197106395491/10197106395493, Lot Numbers: 507547; 80) SANCGADA16, UDI/DI (CS/EA) 50197106582785/10197106582787, Lot Numbers: 510247; 81) SANCGADACC, UDI/DI (CS/EA) 50195594513069/10195594513061, Lot Numbers: 504556, 505054, 505508, 506081, 506339, 508144, 509198, 509199, 509539, 510457, 511246, 511396, 511418, 511584; 82) SANDHCCCFD, UDI/DI (CS/EA) 50197106084142/10197106084144, Lot Numbers: 10737, 23074, 30848, 989938; 83) SANDHCCCFE, UDI/DI (CS/EA) 50197106269242/10197106269244, Lot Numbers: 49746, 60490, 65227, 73529, 87442, 102389, 114050, 144089, 159636, 175216, 192787, 211938, 234735, 238834, 265475; 84) SANOCCPJC1, UDI/DI (CS/EA) 50195594511874/10195594511876, Lot Numbers: 752887; 85) SANOCCPJC2, UDI/DI (CS/EA) 50197106425952/10197106425954, Lot Numbers: 116410; 86) SANOCCPJCG, UDI/DI (CS/EA) 50195594383440/10195594383442, Lot Numbers: 1433, 20410, 37915, 58904, 68192, 78018, 97437, 107018, 127227, 157650, 175561, 700700, 713935, 716576, 728845, 792092, 816966, 822861, 843711, 862089, 891362, 904697, 920727, 938081, 962614, 978544; 87) SANOCIRRS1, UDI/DI (CS/EA) 50195594421296/10195594421298, Lot Numbers: 713853; 88) SANOCIRRSA, UDI/DI (CS/EA) 50888439938140/10888439938142, Lot Numbers: 540460; 89) SANOCIRRSB, UDI/DI (CS/EA) 50195594128744/10195594128746, Lot Numbers: 640781, 784368; 90) SBA73SPVL7, UDI/DI (CS/EA) 50195594806406/10195594806408, Lot Numbers: 899809; 91) SBA73SPVL8, UDI/DI (CS/EA) 50197106242849/10197106242841, Lot Numbers: 35869; 92) SBA73SPVL9, UDI/DI (CS/EA) 50197106536085/10197106536087, Lot Numbers: 197579; 93) SBA73SPVLF, UDI/DI (CS/EA) 50885425845208/10885425845200, Lot Numbers: 16155, 63787, 99032, 143098, 170409, 240762, 241499, 245278, 247305, 276504, 293596, 309173, 337182, 361886, 410637, 439268, 459834, 497113, 526505, 539785, 566502, 578842, 608338, 636714, 663417, 697261, 727520, 734984, 750996, 775553, 807173, 828718, 844150, 874016, 925273, 954345, 972344, 994876; 94) SCV56RH113, UDI/DI (CS/EA) 50888439908105/10888439908107, Lot Numbers: 497961; 95) SCV56RH114, UDI/DI (CS/EA) 50888439939789/10888439939781, Lot Numbers: 516490; 96) SCV56RH115, UDI/DI (CS/EA) 50888439971840/10888439971842, Lot Numbers: 542923; 97) SCV56RH116, UDI/DI (CS/EA) 50195594953209/10195594953201, Lot Numbers: 573745; 98) SCV56RH117, UDI/DI (CS/EA) 50195594016737/10195594016739, Lot Numbers: 599634; 99) SCV56RH118, UDI/DI (CS/EA) 50195594073815/10195594073817, Lot Numbers: 616652; 100) SCV56RH119, UDI/DI (CS/EA) 50195594142672/10195594142674, Lot Numbers: 633862; 101) SCV56RH120, UDI/DI (CS/EA) 50195594278272/10195594278274, Lot Numbers: 670289; 102) SCV56RH121, UDI/DI (CS/EA) 50195594432858/10195594432850, Lot Numbers: 719026; 103) SCV56RH122, UDI/DI (CS/EA) 50195594558732/10195594558734, Lot Numbers: 775188; 104) SCV56RH123, UDI/DI (CS/EA) 50195594578532/10195594578534, Lot Numbers: 784811; 105) SCV56RH124, UDI/DI (CS/EA) 50195594643728/10195594643720, Lot Numbers: 814250; 106) SCV56RH125, UDI/DI (CS/EA) 50195594682246/10195594682248, Lot Numbers: 834779; 107) SCV56RH126, UDI/DI (CS/EA) 50195594716330/10195594716332, Lot Numbers: 849448; 108) SCV56RH127, UDI/DI (CS/EA) 50195594783271/10195594783273, Lot Numbers: 888743; 109) SCV56RH128, UDI/DI (CS/EA) 50197106124862/10197106124864, Lot Numbers: 982198; 110) SCV56RH19V, UDI/DI (CS/EA) 50887488885283/10887488885285, Lot Numbers: 220166, 253448, 285427, 321675, 341181, 373264, 395352, 403333, 470216, 697534, 742395, 903600, 929653, 948079

Distribution pattern

Nationwide

device · product 2 of 4

Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV12; 5) Cardiac Catheterization Kit, Catalog Number SAN73CCV13; 6) Cardiac Catheterization Kit, Catalog Number SAN73CCV14; 8) Cardiac Catheterization Kit, Catalog Number SAN73CCVD8; 9) Cardiac Catheterization Kit, Catalog Number SAN73CCVD9; 10) Cardiac Catheterization Kit, Catalog Number SAN73CCVDG; 11) Cardiac Catheterization Kit, Catalog Number SAN73CCVDH; 12) Cardiac Catheterization Kit, Catalog Number SAN73CCVDI

Z-2328-2024
Recall number
Z-2328-2024
Initiated
May 29, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
2524 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

Code information

1) SAN69CCKRB, UDI/DI (CS/EA) 50195594062079/10195594062071, Lot Numbers: 205373; 2) SAN73CCV10, UDI/DI (CS/EA) 50195594753557/10195594753559, Lot Numbers: 870093; 3) SAN73CCV11, UDI/DI (CS/EA) 50195594870773/10195594870775, Lot Numbers: 915202; 4) SAN73CCV12, UDI/DI (CS/EA) 50197106021987/10197106021989, Lot Numbers: 934300; 5) SAN73CCV13, UDI/DI (CS/EA) 50197106371433/10197106371435, Lot Numbers: 86630; 6) SAN73CCV14, UDI/DI (CS/EA) 50197106559763/10197106559765, Lot Numbers: 209283; 8) SAN73CCVD8, UDI/DI (CS/EA) 50195594589613/10195594589615, Lot Numbers: 791638; 9) SAN73CCVD9, UDI/DI (CS/EA) 50195594615961/10195594615963, Lot Numbers: 803098; 10) SAN73CCVDG, UDI/DI (CS/EA) 50195594546531/10195594546533, Lot Numbers: 29048, 52931, 69859, 821471, 843529, 890800, 951235, 980133, 998592; 11) SAN73CCVDH, UDI/DI (CS/EA) 50197106375516/10197106375518, Lot Numbers: 106841, 149021, 227027, 258282; 12) SAN73CCVDI, UDI/DI (CS/EA) 50197106642007/10197106642009, Lot Numbers: 265079

Distribution pattern

Nationwide

device · product 3 of 4

Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM; 5) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAS; 6) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAT; 7) Cardiovascular Procedure Kit, Catalog Number SANOCAENSA; 8) Cardiovascular Procedure Kit, Catalog Number SCV29ANCCA; 9) Left Heart Kit, Catalog Number SAN73LHKCC; 10) Left Heart Kit, Catalog Number SAN73LHKC6

Z-2329-2024
Recall number
Z-2329-2024
Initiated
May 29, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
17445 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

Code information

1) SAN29ANCC3, UDI/DI (CS/EA) 50888439692868/10888439692860, Lot Numbers: 377162; 2) SAN29ANCC4, UDI/DI (CS/EA) 50888439791929/10888439791921, Lot Numbers: 404590; 3) SAN29ANCCL, UDI/DI (CS/EA) 50887488572077/10887488572079, Lot Numbers: 227924, 248336, 268411, 295823, 330354, 441771, 470382, 485647; 4) SAN29ANCCM, UDI/DI (CS/EA) 50888439916933/10888439916935, Lot Numbers: 538664; 5) SAN33CDCAS, UDI/DI (CS/EA) 50195594100887/10195594100889, Lot Numbers: 7500, 27481, 47777, 66619, 84103, 98759, 654804, 664274, 670490, 690813, 719128, 742731, 769997, 789979, 806872, 821751, 853574, 892089, 905085, 929736, 955110, 974399, 989732; 6) SAN33CDCAT, UDI/DI (CS/EA) 50197106394401/10197106394403, Lot Numbers: 105901, 124750, 166138, 184313, 213752, 228035, 247566; 7) SANOCAENSA, UDI/DI (CS/EA) 50195594650863/10195594650865, Lot Numbers: 60783, 75070, 104936, 117262, 149856, 164959, 192358, 195004, 265705, 842090, 846704, 868814; 8) SCV29ANCCA, UDI/DI (CS/EA) 50888439972533/10888439972535, Lot Numbers: 35435, 51272, 106300, 186438, 257038, 583559, 619303, 639545, 668446, 721926, 744092, 783887, 806636, 868787, 896632, 933968, 969941, 985419; 9) SAN73LHKCC, UDI/DI (CS/EA) 50195594056344/10195594056346, Lot Numbers: 25179, 29199, 52789, 124487, 137706, 203053, 756293, 826474; 10) SAN73LHKC6, UDI/DI (CS/EA) 50197106375561/10197106375563, Lot Numbers: 89496

Distribution pattern

Nationwide

device · product 4 of 4

Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA

Z-2330-2024
Recall number
Z-2330-2024
Initiated
May 29, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
13487 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

Code information

1) SAN29NICCA, UDI/DI (CS/EA) 50197106228256/10197106228258, Lot Numbers: 36457; 2) SAN29NRCC1, UDI/DI (CS/EA) 50888439733509/10888439733501, Lot Numbers: 381858; 3) SAN29NRCC2, UDI/DI (CS/EA) 50195594325563/10195594325565, Lot Numbers: 685160; 4) SAN29NRCC3, UDI/DI (CS/EA) 50195594622532/10195594622534, Lot Numbers: 801575; 5) SAN29NRCCA, UDI/DI (CS/EA) 50888439636374/10888439636376, Lot Numbers: 28512, 42260, 69660, 85314, 103254, 127809, 140829, 183868, 213751, 227923, 240464, 251395, 268874, 345018, 393999, 409767, 428188, 443499, 450337, 493647, 516110, 532267, 558093, 579539, 607101, 629107, 653793, 713103, 736984, 760148, 840293, 860356, 884815, 911567, 927802, 951008, 972525; 6) SANV1NIYH2, UDI/DI (CS/EA) 50195594812117/10195594812119, Lot Numbers: 900859; 7) SANV1NIYH3, UDI/DI (CS/EA) 50195594854292/10195594854294, Lot Numbers: 910887; 8) SANV1NIYH4, UDI/DI (CS/EA) 50197106022526/10197106022528, Lot Numbers: 935906; 9) SANV1NIYH5, UDI/DI (CS/EA) 50197106182060/10197106182062, Lot Numbers: 8317; 10) SANV1NIYH6, UDI/DI (CS/EA) 50197106184606/10197106184608, Lot Numbers: 10606; 11) SANV1NIYH7, UDI/DI (CS/EA) 50197106550302/10197106550304, Lot Numbers: 206131; 12) SANV1NIYHD, UDI/DI (CS/EA) 50888439951804/10888439951806, Lot Numbers: 586552, 619022, 623318, 643076, 665586, 708746, 735601, 759729, 779438, 791843, 822259, 841189, 863424, 884486, 892439, 952549, 960592, 980278, 982298; 13) SANV1NIYHE, UDI/DI (CS/EA) 50197106142910/10197106142912, Lot Numbers: 141514; 14) SANV1NIYHF, UDI/DI (CS/EA) 50197106482221/10197106482223, Lot Numbers: 157881, 168214, 228005, 237862, 262336, 267274; 15) SANV2INEH4, UDI/DI (CS/EA) 50197106029129/10197106029121, Lot Numbers: 937561; 16) SANV2INEHG, UDI/DI (CS/EA) 50195594755414/10195594755416, Lot Numbers: 927680; 17) SANV2INEHH, UDI/DI (CS/EA) 50197106029365/10197106029367, Lot Numbers: 8892, 10096, 14350, 36037, 120832, 134410, 215368, 224862, 238592, 243572, 967590; 18) SNE29NRCCC, UDI/DI (CS/EA) 50887488772705/10887488772707, Lot Numbers: 236962, 236962, 256027, 257466, 287291, 287291, 318482; 19) SNECGMEUCA, UDI/DI (CS/EA) 50197106387724/10197106387726, Lot Numbers: 98094, 156243; 20) SNECGNIUC3, UDI/DI (CS/EA) 50197106605873/10197106605875, Lot Numbers: 238196; 21) SNECGNIUCA, UDI/DI (CS/EA) 50197106045525/10197106045527, Lot Numbers: 48591, 172310, 203428, 223186, 247687, 265553, 980874; 22) SNEMHNTWD1, UDI/DI (CS/EA) 50197106251780/10197106251782, Lot Numbers: 37065; 23) SNEMHNTWDA, UDI/DI (CS/EA) 50195594826039/10195594826031, Lot Numbers: 129007, 163637, 206874, 938377, 972171

Distribution pattern

Nationwide