Device product
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
Z-0158-2015
Product summary
- Event
- Event 58185
- Status
- Terminated
- Classification
- Class II
- Quantity
- 777 units
- Official record key
device-enforcement:Z-0158-2015
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, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 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