Recall Z-0808-2007 ยท GAW Suture, Nonabsorbable, Synthetic, Polypropylene
C P Medical
Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positione
| 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 | 1332 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
| K001185 | POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP Cp Medical, Jun 23, 2000 |