Recall Z-1173-2023 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
Covidien, LP
Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12
| 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 | 12732 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
| K900531 | NONABSORBABLE NYLON SURGICAL SUTURE* United States Surgical, A Division of Tyco Healthc, Jul 5, 1990 |