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

Covidien, LP: Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 S

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: 8604 units Lot/code info: GTIN: 20884521037868, 20884521036519, 20884523004387, 20884521036540, 20884521037868. Model Number Lot # CP535 D2C1521Y D2E1342Y D2E1580Y D2E2678Y D2E2679Y D2F0509Y CP824 D2D0251Y CP825 D2C3234Y VP543 D2B1270Y D2D1493Y D2E1389Y

UPC codes

20884521037868, 20884521036519, 20884523004387, 20884521036540

Source

Official record: FDA (Device enforcement)

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

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