Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil
FDA device recall Z-0260-2012 · posted 2011-11-19 · Terminated
Recall details
- Recalling firm
- C P Medical Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 13632 sutures
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-01-02
- Date posted
- 2011-11-19
- Date terminated
- 2011-12-13
- Location
- Portland, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) (K002190) | Cp Medical | 2000-08-10 |