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FDA (Device enforcement)Recalled 2022-12-02class ii

Covidien, LP: Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMAL

Hazard

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Details from the source

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 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 Jord Quantity: 9606 Lot/code info: GTIN: 10884521070981 20884521070988 20884521070797 10884521070790 20884521070797 20884521070698 10884521070691 20884521070834 10884521070806 20884521070803 20884521070698 10884521070691 20884521070797 Lot # (1) D2B0701Y, D2E3000Y (2) D1M2315FY, D1M2326FY,D2F1873FY (3) D2B2781FY (4) D2B1309FY (5) D1J0777FY

UPC codes

10884521070981, 20884521070988, 20884521070797, 10884521070790, 20884521070698, 10884521070691, 20884521070834, 10884521070806, 20884521070803

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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