Recall Z-0809-2007 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
C P Medical
Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or visible through the foil wrap which must be torn to have access to the suture and needle. Product
| Date | May 24, 2007 (initiated Apr 3, 2007) |
| Status | Terminated |
| Reason | Potential for sterility of product to be compromised. Suture package seals incomplete or missing. |
| Root cause | Other |
| Action | On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical. On 04/20/2007 the firm noti |
| Quantity | 13,596 suture packets |
| Distribution | Firm distributes products to human and veterinary medical device distribution centers worldwide. Polybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa. Polypropelene sutures, product 8665, were distributed to veterinary distribution centers in OH |
| 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 |