FDA Enforcement
Class II
Terminated
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
Recall: Z-0161-2015
·
Reported November 12, 2014
Enforcement
- Recall Number
- Z-0161-2015
- Event ID
- 58185
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 12, 2014
- Initiation Date
- March 1, 2011
- Classification Date
- October 31, 2014
- Termination Date
- November 6, 2014
- Address
- 28 Howe St, N/A, Ashland, MA, 01721-1305, United States
Description
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
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 Info
Lot Numbers: MN08 Manufacturing Date November 8, 20 I 0.
Distribution
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Quantity
24 units