Covidien, LP: Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440

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: 48492 units Lot/code info: GTIN 20884521100821, 20884521100098, 10884521100091, 10884521100299, 20884521100296, 20884521099910, 20884521100814, 20884521100791, 20884521100593, 20884521099965, 20884521099477, 20884521100760, 20884521118345, 10884521118348, 20884521099682, 20884521118406, 20884521099699, 20884521100838, 20884521099699, 20884521118390, 10884521118393, 20884521100890, 10884521100893, 20884521099569, 20884521100692, 20884521100074, 20884521099583, 20884521100876, 20884521100777. Model # Lot #: 8886400241 D1G1762FY, 8886440013 D2A0461Y, 8886440023 D1M0797Y, 8886440123 D1L3389Y, 8886440233 D2A0529Y, 8886440333 D2C0582Y, 8886441003 D1M1007FY, D1M2364FY 8886441013 D1M1007FY D1M2364FY, 8886441003 D1M0369FY D1M0796FY, 8886442243 D1D2485FY, 8886442451 D1E1240FY, 8886445041 D2B2109Y, 8886445251 D1D0295Y, D1E0843Y, 8886445961 D1D0529Y, 8886447081 D1D3190Y, 8886458253 D2B1686FY, SPB1213G D1L0169FY, D2B0773FY D2C0769FY, SPB1233G D2E0961FY, SPB1623G D1D2709FY, SPB5142G D1B2811FY, SPB5143G D1D2674FY, SPB5223G D1M1024FY, SPB5433G D2C1970FY, SPB5633G D2A0500FY, SPB-5223G D1M1024FY

UPC codes

20884521100821, 20884521100098, 10884521100091, 10884521100299, 20884521100296, 20884521099910, 20884521100814, 20884521100791, 20884521100593, 20884521099965, 20884521099477, 20884521100760, 20884521118345, 10884521118348, 20884521099682, 20884521118406, 20884521099699, 20884521100838, 20884521118390, 10884521118393, 20884521100890, 10884521100893, 20884521099569, 20884521100692, 20884521100074, 20884521099583, 20884521100876, 20884521100777

Source

Official record: FDA (Device enforcement) ↗

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