Recall Z-0158-2015 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
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.
| Date | Oct 31, 2014 (initiated Mar 1, 2011) |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | 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 rep |
| Quantity | 777 units |
| Distribution | Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K823451 | CLEAR CARDIOPLEJIA DELIVERY SYSTEM 3M Health Care, Sarns, Jan 14, 1983 |