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
This recall has been terminated (originally issued October 31, 2014).
- Recall Initiated
- March 1, 2011
- Posted
- October 31, 2014
- Terminated
- November 6, 2014
- Recall Number
- Z-0161-2015
- Quantity
- 24 units
- Firm Location
- Ashland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Lot / Code Info
Lot Numbers: MN08 Manufacturing Date November 8, 20 I 0.
Root Cause
Device Design
Action Taken
Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.