Monosof Monofilament Nylon sutures: Product Description recall: Sterility Concern
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*…
Why was Monosof Monofilament Nylon sutures: Product Description recalled?
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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-3697 D1L1710FY D2C1211FY SN-3965 D1E1222Y SN-5660G D1L0922FY SN-5665G D1L0774FY SN-5690G D1M1283FY SN-5691 D2D0703FY SN-5694 D1J1230FY SN-5696 D1M2419FY SN-5697 D2F0399FY SN-5767G D2A0554FY SN-630 D1M1286FY SN-643 D2B0369FY SN-667G D1L2502FY SN-694 D2C0324FY SN-871 D1K3362FY SN-872 D1K2654FY D1M2450FY GNJ-283 D1E0555Y D1E0750Y N-59 D2D2350Y
- 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*…
- Recalling firm
- Covidien, LP
- Quantity
- 54288 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 Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)