Recall Z-1542-2013 ยท DWS Instruments, Surgical, Cardiovascular
Edwards Lifesciences, LLC
QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickD
| Date | Jun 13, 2013 (initiated May 14, 2013) |
| Status | Terminated |
| Reason | Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used. |
| Root cause | Process design |
| Action | The firm, Edwards Lifesciences, sent an "URGENT FIELD SAFETY NOTICE PRODUCT RECALL - ACTION REQUIRED" notice dated May 14, 2013 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to review our entire inventory for any QuickDraw Venus Cannula that has not expired; quarantine affected product from your inventory; discontinue use and return unused devices; complete and return the acknowledgment form via fax to Edwards Customer Service on 800-422-9329 within three days of receipt of this Field Safey Notice; contact Customer Servic |
| Quantity | 22,616 |
| Distribution | Worldwide distribution: US Nationwide and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981995 | QUICKDRAW VENOUS CANNULA Heartport, Inc., Apr 20, 1999 |