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
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- May 29, 2024
- Posted
- July 10, 2024
- Recall Number
- Z-2328-2024
- Quantity
- 2524 units
- Firm Location
- Waukegan, IL
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
Lot / Code Info
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
Root Cause
Device Design
Action Taken
Cardinal Health issued an URGENT: PRODUCT RECALL notice to its consignees on 05/28/2024 via letter. The notice explained the issue, potential risks involved, and requested the following: "If you locate affected product within your facility, please complete the following: 1. QUARANTINE affected kits & ALERT your clinicians of this action 2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all syringes within the affected Merit Medical kit in the Presource product. 3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: gmb-FieldCorrectiveAction@cardinalhealth.com For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166 If you are a Distributor and have further distributed affected kits, please notify your customers of this recall." Expansion letter was sent via FedEx Express on 6/20/2024