Recall Z-1176-2023 ยท GAP Suture, Nonabsorbable, Silk
Covidien, LP
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172 S-1173 SOFSILK* 5-0 BLK 45CM C1 X36 S1173 S-1174 SOFSILK* 4-0 BLK 45CM C1 X36
| Date | Feb 25, 2023 (initiated Dec 2, 2022) |
| Status | Open, Classified |
| Reason | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| Root cause | Packaging process control |
| Action | Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter to US consignees on 01-Dec-2022 via UPS 2-day delivery. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Actions: " Identify and quarantine all unused and non-expired affected non-absorbable sutures. " Please note the affected product may be located within Custom Suture Packs. Please reference Custom Suture Packs to identify affected product. " Please complete the enclosed Customer Confirmation Form (even if your account no longer has affected |
| Quantity | 271800 units |
| Distribution | US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Geor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981128 | SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc, May 11, 1998 |