Cardinal Health 200, LLC: Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN1

Hazard

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.

Details from the source

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: Nationwide Quantity: 136753 units Lot/code info: 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,

UPC codes

50888439661574, 10888439661576, 50195594317339, 10195594317331, 50195594746986, 10195594746988, 50195594778772, 10195594778774, 50197106253227, 10197106253229, 50887488801436, 10887488801438, 50888439596357, 10888439596359, 50195594473073, 10195594473075, 50195594635730, 10195594635732, 50195594796813, 10195594796815, 50197106250646, 10197106250648, 50888439268834, 10888439268836, 50195594942180, 10195594942182, 50197106258901, 10197106258903, 50195594092663, 10195594092665, 50195594489784, 10195594489786, 50195594524362, 10195594524364, 50197106068760, 10197106068762, 50195594004093, 10195594004095, 50197106074945, 10197106074947

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.