Monosof Monofilament Nylon sutures: Product Description CN-724… — Class II medical device recall Z-1174-2023
Ongoing recall by Covidien, LP, reported 2023-03-08, distributed nationwide. Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases
| Recall number | Z-1174-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2022-12-02 |
| Classified | 2023-02-25 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 54,288 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10884521075146, 10884521075238, 10884521078758, 10884521079090, 10884521079137, 10884521079328, 10884521080324, 10884521080348, 10884521635371, 10884521635395, 20884521075105, 20884521075129, 20884521075143, 20884521075235, 20884521075372, 20884521076812, 20884521076829, 20884521077857, 20884521077987, 20884521077994, 20884521078045, 20884521078090, 20884521078182, 20884521078755, 20884521079028 and 12 more |
| Lot numbers | CN-724, CN-791, CN-79112, CN-793, CN-79312, CN-830-L, D1B2528Y, D1D2705Y, D1D2772Y, D1D3222FY, D1E0555Y, D1E0750Y, D1E1222Y, D1G0954FY, D1J1230FY, D1K2654FY, D1K3362FY, D1L0774FY, D1L0922FY, D1L0957FY, D1L1710FY, D1L1776Y, D1L2330Y, D1L2502FY, D1M1283FY, D1M1286FY, D1M2419FY, D1M2450FY, D2A0554FY, D2B0043FY, D2B0369FY, D2B2227FY, D2B2754Y, D2C0324FY, D2C1211FY, D2C1333FY, D2D0703FY, D2D2350Y, D2E2028FY, D2E2761FY and 27 more |
| Model numbers | CN-724, CN-791, CN-79112, CN-793, CN-79312, CN-830-L, D1B2528Y, D1D2705Y, D1D2772Y, D1D3222FY, D1E0555Y, D1E0750Y, D1E1222Y, D1G0954FY, D1J1230FY, D1K2654FY, D1K3362FY, D1L0774FY, D1L0922FY, D1L0957FY, D1L1710FY, D1L1776Y, D1L2330Y, D1L2502FY, D1M1283FY and 42 more |
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 for recall
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1174-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.