Recall Z-2196-2011 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences Llc
Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
| Date | May 13, 2011 (initiated Jan 21, 2011) |
| Status | Terminated |
| Reason | Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation. |
| Root cause | Other |
| Action | The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated January 21, 2011 it customers via Fed-Ex. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory for any of the lot numbers; return all unused product from their stock to Edwards; contact their Customer Service Organization at (800) 424-3278 to obtain a Returned Goods Authorization number and replacement product; complete and return the Aortic Perfusion Cannula Recall Response form via fax to: Edwards at (949) 250-3489, and return u |
| Quantity | 20 |
| Distribution | Nationwide distribution: CA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033463 | EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE Edwards Lifesciences, LLC, Jul 28, 2004 |