Recall Z-1027-2019 ยท GAL Suture, Absorbable, Natural
CP Medical Inc
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.
| Date | Feb 4, 2019 |
| Status | Open, Classified |
| Reason | Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result. |
| Root cause | Under Investigation by firm |
| Action | CP Medical initially notified consignees via telephone call on about 02/01/2019. Consignees were gain notified via "URGENT: Recall Notice" via email on about 02/04/2019 and followed up with the same letter sent via FedEx on about 02/20/2019. Instructions included to immediately discontinue selling or using the affected product, return any affected product back to CP Medical, notify customers if the affected product was further distributed, and complete and return the "Recall Checklist." A request for a Returns Goods Authorization (RGA) and questions can be directed to Customer Service a |
| Quantity | 1,905 boxes (22,860 sutures total) |
| Distribution | Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001299 | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP Cp Medical, Jun 23, 2000 |