Recall Z-3177-2011 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
C P Medical Inc.
Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. The products are labeled in parts. These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
| Date | Sep 9, 2011 (initiated Jun 29, 2011) |
| Status | Terminated |
| Reason | Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material. |
| Root cause | Process control |
| Action | CP Medical sent a "RECALL NOTICE" letter dated June 29, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products in the human market and to return all their existing stock. A Recall Checklist was enclosed for customers to complete and return. Contact Customer Service at 1-800-950-2763 for a Return Good Authorization and shipping account number. The firm will pay for shipping cost and replace product at no cost to customers. |
| Quantity | 776 dozens boxes |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP Cp Medical, Jun 23, 2000 |