Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Reason for recall: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northe Quantity: 135,875 total Lot/code info: BOX06614V4 UDI-DI 00199150037902 Lots 0233506453 0233506454 0233506455 0233506456 BOX07405V1 UDI-DI 00763000960186 Lot 0233617676 BOX01056V2 UDI-DI 00763000593711 Lot 0233484641 BOX01482V2 UDI-DI 00763000457990 Lot 0233607201 BOX09222V1 UDI-DI 00199150066636 Lot 0233577301 BOX08767V1 UDI-DI 00199150034338 Lot 0233598575 JAWBYPASS2 UDI-DI 00763000931988 Lots 0233608008 0233608009 BOX02191V11 UDI-DI 00199150038022 Lots 0233514888 0233586164 0233586169 0233587200 0234047180 BOX06863V4 UDI-DI 00763000991654 Lots 0233560359 0234087501 PST04884V3 UDI-DI 00763000523954 Lots 0233514943 0234035336 PST04884V6 UDI-DI 00763000646820 Lots 0233476937 0233550564 0233609032 BOX08506V2 UDI-DI 00199150028627 Lots 0234121845 0234122488 0234122495 0234122500 0234122505 0234122509 KIT00625V1 UDI-DI 00199150033874 Lot 0233646102 KIT01026V1 UDI-DI 00199150033867 Lot 0233646101 BOX00051V4 UDI-DI 00763000967765 Lots 0233560350 0233570153 0233584284 0233606897 PST03130V2 UDI-DI 00763000911096 Lot 0233628870 UCKGB5 UDI-DI 00763000910549 Lot 0233600730 WEJRYGB3 UDI-DI 00763000975326 Lot 0233547345 VLOCL0013 UDI-DI 20884521130361 Lot A5M1176VFY VLOCL0014 UDI-DI 20884521130378 Lot A6A0972VFY VLOCL0023 UDI-DI 20884521130408 Lot A5M1175VFY VLOCL0024 UDI-DI 20884521130415 Lot A5M1224VFY VLOCL0306 UDI-DI 10884521130944 Lot A6A0996VY UDI-DI 20884521130941 Lot A6A0996VY VLOCL0316 UDI-DI 10884521131316 Lot A5M1060VY UDI-DI 20884521131313 Lots A5M1060VY A6A0994VY VLOCL0345 UDI-DI 20884521131047 Lot A5M1165VY VLOC
00199150037902, 00763000960186, 00763000593711, 00763000457990, 00199150066636, 00199150034338, 00763000931988, 00199150038022, 00763000991654, 00763000523954, 00763000646820, 00199150028627, 00199150033874, 00199150033867, 00763000967765, 00763000911096, 00763000910549, 00763000975326, 20884521130361, 20884521130378, 20884521130408, 20884521130415, 10884521130944, 20884521130941, 10884521131316, 20884521131313, 20884521131047, 20884521131085, 20884521131139, 10884521131132, 20884521131160, 20884521131238, 20884521131269, 10884521131286, 20884521131283, 10884521131538, 20884521131535, 10884521131545, 20884521131542, 20884521762494
Official record: FDA (Device enforcement) ↗
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