Device product
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 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-0157-2015
Product summary
- Event
- Event 58185
- Status
- Terminated
- Classification
- Class II
- Quantity
- 165 units
- Official record key
device-enforcement:Z-0157-2015
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: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 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