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
Published July 17, 2024 · Recall initiated: May 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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