Recall Z-0259-2012 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
C P Medical Inc.
Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet, monofilament synthetic absorbable suture with needle, size 4/0 (1.5 Metric), NFS-2 Needle (Produc
| Date | Nov 19, 2011 (initiated Jan 2, 2009) |
| Status | Terminated |
| Reason | The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch. |
| Root cause | Nonconforming Material/Component |
| Action | CP Medical, Inc. sent a "RECALL NOTICE" letter dated January 5, 2009 to all affected customers.The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to identify affected product and to return the product to the firm. Customers should call 1-503-232-1555 for a return goods authorization number and shipping account number. Contact your customer service representative at 1-800-950-2763 for questions concerning this recall. |
| Quantity | 13632 sutures |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013274 | MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE Cp Medical, Nov 16, 2001 |