Recall Z-1178-2023 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
Covidien, LP
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 BLK 7X75CM PCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT 88861932-51 SURGILON* 2-0 BLK 75CM GS10 88861971-71 SURGILON* 1 BLK 75CM G
| 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 | 87708 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
| K981582 | SURGILON, DERMALON, & OPHTHALON Davis & Geck, Inc., Jul 13, 1998 |