Recall Z-2601-2018 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Covidien LLC
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
| Date | Jun 15, 2018 |
| Status | Terminated |
| Reason | Potential proplylene glycol contamination |
| Root cause | Nonconforming Material/Component |
| Action | All U.S. consignees were notified via Federal Express or certified mail on June 15, 2018, and the letter informs customers of the potential that the suture was contaminated with propylene glycol during the manufacturing process and the actions they should take. Customers are advised to discontinue use of the product and return all inventory of the affected lot to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. |
| Quantity | 972 units |
| Distribution | CA, NY & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981935 | POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc, Jun 25, 1998 |