Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different nee
FDA device recall Z-3177-2011 · posted 2011-09-09 · Terminated
Recall details
- Recalling firm
- C P Medical Inc.
- Reason for recall
- Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GAR
- Quantity affected
- 776 dozens boxes
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan.
- Date initiated
- 2011-06-29
- Date posted
- 2011-09-09
- Date terminated
- 2012-05-24
- 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 |
|---|---|---|
| NYLON, NONABSORBABLE SURGICAL SUTURES USP (K001173) | Cp Medical | 2000-06-23 |