Z-2328-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2024
- Initiation Date
- May 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2524 units
Product Description
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
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
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