Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIO...
FDA Device Recall #Z-2327-2024 — Class II — May 29, 2024
Recall Summary
| Recall Number | Z-2327-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 29, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cardinal Health 200, LLC |
| Location | Waukegan, IL |
| Product Type | Devices |
| Quantity | 136753 units |
Product Description
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,
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.
Distribution Pattern
Nationwide
Lot / 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
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.