Covidien, LP: Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS56

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: 271800 units Lot/code info: GTIN: 20884521086781, 20884521758060, 20884521088136, 20884521088525, 20884521087504, 20884521085289, 20884521087672, 20884521087481, 20884521090566, 20884521086712, 20612479214235, 10884521084698, 20884521084695, 20884521085166, 20884521087580, 10884521087583, 20884521089256, 20884521088532, 20884521087719, 20884521090160, 10884521090163, 20884521087900, 20612479214419, 20884521083629, 20884521085944, 20884521086668, 20884521087399, 10884521086142, 20884521086149, 10884521086623, 20884521086620, 20884521106106, 20884521085968, 20884521086484, 20884521086491, 10884521086494, 20884521088624, 10884521086661, 20884521086170, 20884521085951, 10884521086463, 20884521086460, 20884521086187, 10884521085787, 20884521085784, 20884521085517, 20884521090184, 20612479214495, 20884521090153, 20884521086651, 10884521085510, 20884521088464, 20884521088129, 20884521086194, 10884521086197, 20884521086552, 10884521087484, 20884521085982, 10884521085985, 20884521086477, 20884521106021, 20884521106052, 20884521757926, 10884521083622, 20612479213283, 20884521090115, 10884521090118, 20884521085746, 20884521087429, 20884521086774, 20884521085975, 20884521088143, 20884521086705, 20884521085470, 20884521085500, 20884521084671, 10884521084674, 20884521758039, 20612479213269, 10884521085169, 20884521086514, 20884521086200, 20884521106045, 20884521085739, 20884521086422. Model Number Lot # CS211 D1L1576Y D2B0747Y CS490 D2C2519Y CS562 D1G1928Y GS823 D1K1923Y D2D1396Y GS835 D1E1757Y S1172 D2C2304Y S1173 D

UPC codes

20884521086781, 20884521758060, 20884521088136, 20884521088525, 20884521087504, 20884521085289, 20884521087672, 20884521087481, 20884521090566, 20884521086712, 20612479214235, 10884521084698, 20884521084695, 20884521085166, 20884521087580, 10884521087583, 20884521089256, 20884521088532, 20884521087719, 20884521090160, 10884521090163, 20884521087900, 20612479214419, 20884521083629, 20884521085944, 20884521086668, 20884521087399, 10884521086142, 20884521086149, 10884521086623, 20884521086620, 20884521106106, 20884521085968, 20884521086484, 20884521086491, 10884521086494, 20884521088624, 10884521086661, 20884521086170, 20884521085951

Source

Official record: FDA (Device enforcement) ↗

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