Recall Z-1297-2020 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Covidien LLC
Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
| Date | Feb 19, 2020 (initiated Dec 18, 2019) |
| Status | Terminated |
| Reason | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. |
| Root cause | Equipment maintenance |
| Action | On December 18, 2109, Medtronic issued Urgent Medical Device Recall and Return Form notices to customers via courier service. Customers were advised to take the following required actions: 1. Please immediately quarantine and discontinue use of the affected item code and lot listed within the notice. 2. Please return affected product as indicated within the notice. All unused products from the affected item codes and lots must be returned. 3. If you have distributed any of the Polysorb braided or Biosyn monofilament absorbable sutures listed on the recall notice, please promptly forward |
| Quantity | 139,938 units total |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000037 | MONOFILAMENT BIOSYN SUTURE United States Surgical, A Division of Tyco Healthc, Mar 30, 2000 |