FDA Device recall Z-1174-2023
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-…
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-… by Covidien, citing sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1174-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-02 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12 CN-830-L MONOSOF* 1 BLK 150CM LP GS25 N-2781K MONOSOF* 5-0 BLK 45CM SS24 DAX12 SN-1647 MONOSOF* 7-0 BLK 45CM P16 X36 SN-1647G MONOSOF* 7-0 BLK 45CM P16 X12 SN-247 MONOSOF* 3-0 BLK 90CM C23 X36 SN-3686 MONOSOF* 7-0 BLK 45CM P10 X12 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 SN-3697 MONOSOF* 6-0 BLK 45CM P10 X12 SN-3965 MONOSOF* 5-0 BLK 45CM PC11 X12 SN-5660G MONOSOF* 6-0 BLK 45CM P24 X12 SN-5665G MONOSOF* 6-0 BLK 45CM P12 X12 SN-5690G MONOSOF* 5-0 CLR 45CM P13 X12 SN-5691 MONOSOF* 4-0 CLR 45CM P13 X36 SN-5694 MONOSOF* 4-0 BLK 45CM P11 X36 SN-5696 MONOSOF* 6-0 BLK 45CM P13 X36 SN-5697 MONOSOF* 6-0 BLK 45CM P10 X36 SN-5767G MONOSOF* 6-0 BLK 45CM P11 X12 SN-630 MONOSOF* 4-0 BLK 75CM C22 X36 SN-643 MONOSOF* 5-0 BLK 75CM C13 X36 SN-667G MONOSOF* 6-0 BLK 45CM C1 X12 SN-694 MONOSOF* 2-0 BLK 90CM C18 X36 SN-871 MONOSOF* 5-0 BLK 45CM C1 X36 SN-872 MONOSOF* 4-0 BLK 45CM C1 X36 SUT GNJ-283 MONOSOF 2/0 BLK ST DA 90CM SUT N-59 MONOSOF 2-0 BLK 6X45CM PCT
Reason
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Identifiers
| code_info | GTIN: 20884521075105, 20884521075235, 10884521075238, 20884521075143, 10884521635395, 20884521077857, 20884521075372, 2…GTIN: 20884521075105, 20884521075235, 10884521075238, 20884521075143, 10884521635395, 20884521077857, 20884521075372, 20884521078090, 20884521077994, 20884521079073, 10884521080348, 20884521080345, 20884521080321, 10884521080324, 10884521078758, 20884521078755, 20884521078182, 20884521078045, 20884521075129, 10884521635371, 20884521127675, 20884521079844, 20884521079028, 20884521079325, 10884521079328, 20884521079097, 10884521079090, 20884521079202, 20884521079448, 20884521076829, 10884521075146, 20884521080093, 20884521079042, A8845210765103, 20884521076812, 20884521077987, 20884521079134, 10884521079137, Model # Lot # CN-724 D1B2528Y CN-791 D1L1776Y CN-79112 D1L1776Y CN-793 D1D2772Y D2B2754Y CN-79312 D1D2772Y CN-830-L D1D2705Y N-2781K D1L2330Y SN-1647 D2E2028FY SN-1647G D2B2227FY SN-247 D1D3222FY D2B0043FY SN-3686 D2E2761FY D2F0402FY SN-3695 D1G0954FY D1L0957FY D2C1333FY D2E2762FY SN |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1174-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.