Uncertainty in the seal integrity of the sterile packaging.
Reason for recall: Uncertainty in the seal integrity of the sterile packaging. Distribution: Worldwide distribution. Quantity: 251,591 units Lot/code info: a) REF 100/210/060, UDI/DI 35019315010990, Lot Numbers: 4147817; UDI/DI 35019315011003, Lot Numbers: 4097683, 4100700; UDI/DI 35019315022399, Lot Numbers: 4089149, 4112945; UDI/DI 35019315022405, Lot Numbers: 4110350, 4115879, 4156815; UDI/DI 35019315022429, Lot Numbers: 4107296; b) REF 100/210/060JP, UDI/DI 35019315022399, Lot Numbers: 4089149, 4104268, 4107295, 4112945, 4133226, 4133228; c) REF 100/210/070, UDI/DI 35019315010952, Lot Numbers: 4147818, 4150795; UDI/DI 35019315010990, Lot Numbers: 4107293, 4122008; UDI/DI 35019315011003, Lot Numbers: 4107294, 4122007; UDI/DI 35019315018156, Lot Numbers: 4088214, 4088217, 4109288; UDI/DI 35019315022399, Lot Numbers: 4104268, 4115880; UDI/DI 35019315022405, Lot Numbers: 4097684, 4104267, 4110348, 4118571, 4156816; UDI/DI 35019315022429, Lot Numbers: 4092462, 4112944; UDI/DI 35019315022559, Lot Numbers: 4104266, 4110349; d) REF 100/210/070JP, UDI/DI 35019315022405, Lot Numbers: 4089150, 4092463, 4097684, 4104267, 4110348, 4110350, 4118570, 4118571, 4122011, 4122012, 4127688, 4133230, 4156815, 4156816; e) REF 100/210/080, UDI/DI 35019315022399, Lot Numbers: 4107295; UDI/DI 35019315011003, Lot Numbers: 4150794; UDI/DI 35019315018156, Lot Numbers: 4088216, 4109287, 4119724; UDI/DI 35019315022405, Lot Numbers: 4089150, 4092463, 4118570; f) REF 100/210/080JP: UDI/DI 35019315022429, Lot Numbers: 4092462, 4100701, 4107296, 4125005, 4127687, 4141737, 4147168; g) REF 100/210/080JS, UDI/DI 35019315022429, Lot Numbers: 4100701; h) REF 100/
35019315010990, 35019315011003, 35019315022399, 35019315022405, 35019315022429, 35019315010952, 35019315018156, 35019315022559
Official record: FDA (Device enforcement) ↗
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