Device product
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
Z-0161-2015
Product summary
- Event
- Event 58185
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-0161-2015
Official wording
Reason: Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line
Code information: Lot Numbers: MN08 Manufacturing Date November 8, 20 I 0.
Distribution pattern: Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Derived failure modes
-
Unknown
Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line