Recall Z-0157-2015 ยท KRI Accessory Equipment, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
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
| 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 | 165 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
| K810079 | SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS 3M Health Care, Sarns, Jan 30, 1981 |