CLASS II ONGOING Device recall · Reported 17 Jul 2024 · FDA Enforcement Report
Presource kits and trays, labeled as: Angiography Pack recalled
Cardinal Health 200 is recalling Presource kits and trays, labeled as: Angiography Pack, distributed nationwide in the US. The recall was initiated on 29 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2327-2024
- FDA event ID
- 94763
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 May 2024
- FDA classified
- 10 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 29 May 2024 | Recall initiated by company | |
| 10 Jul 2024 | Classified by FDA | +42 days |
| 17 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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,
Where it was distributed
Nationwide
Questions about this recall
Is Presource kits and trays, labeled as: Angiography Pack recalled?
Yes. Cardinal Health 200 recalled Presource kits and trays, labeled as: Angiography Pack on 29 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2327-2024.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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