Cardinal Health 200, LLC: Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number S

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: 13487 units Lot/code info: 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) SA

UPC codes

50197106228256, 10197106228258, 50888439733509, 10888439733501, 50195594325563, 10195594325565, 50195594622532, 10195594622534, 50888439636374, 10888439636376, 50195594812117, 10195594812119, 50195594854292, 10195594854294, 50197106022526, 10197106022528, 50197106182060, 10197106182062, 50197106184606, 10197106184608, 50197106550302, 10197106550304, 50888439951804, 10888439951806, 50197106142910, 10197106142912, 50197106482221, 10197106482223, 50197106029129, 10197106029121, 50195594755414, 10195594755416, 50197106029365, 10197106029367, 50887488772705, 10887488772707, 50197106387724, 10197106387726, 50197106605873, 10197106605875

Source

Official record: FDA (Device enforcement) ↗

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