Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Reason for recall: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. Distribution: Worldwide distribution - US Nationwide and the countries of UAE, and Canada. Quantity: 65310 units Lot/code info: 1) REF CDS930177C, UDI/DI 10889942810949 (EA) 40889942810940 (CS), Lot Numbers: 19BBO293, 19CBI818, 19EBC020, 19IBS311, 19JBP366, 19LBY043, 19VBE320, 20CBD448, 21ABE744, 21BBN653; 2) REF CDS982054V, UDI/DI 10193489552799 (EA) 40193489552790 (CS), Lot Numbers: 19BBJ530, 19CBL695, 19EBN805, 19EBZ133; 3) REF CDS982683X, UDI/DI 10198459064548 (EA) 40198459064549 (CS), Lot Numbers: 24IBH460; 4) REF CDS982719X, UDI/DI 10198459064531 (EA) 40198459064532 (CS), Lot Numbers: 24IBE288, 24JBB766, 24KBA129; 5) REF CDS983467J, UDI/DI 10195327561116 (EA) 40195327561117 (CS), Lot Numbers: 24ADA818, 24ADC216, 24BDA929, 24DDB447, 24EDA275, 24EDA751, 24GDB213, 24IDA327, 24IDB043, 24IDB372; 6) REF CDS983470C, UDI/DI 10889942730407 (EA) 40889942730408 (CS), Lot Numbers: 19ADC620, 19BDA241, 19CDA866, 19DDA314, 19DDD395, 19FDB295, 19GDA719, 19HDD614, 19JDB841, 19LDB812; 7) REF CDS983470I, UDI/DI 10195327561154 (EA) 40195327561155 (CS), Lot Numbers: 23LDA393, 24ADC171, 24DDA672, 24EDB254, 24FDC148, 24IDB368; 8) REF CDS983799D, UDI/DI 10193489592030 (EA) 40193489592031 (CS), Lot Numbers: 19FKB592, 19HKC268, 19IKA490, 19IKB968, 19JKA055, 19KKC040, 19LKB631, 20CKA736, 20HKB175, 21FLA865, 21ILA106, 21KLA781, 22ILA060, 22ILA292, 23HLA184; 9) REF CDS985212A, UDI/DI 10193489596335 (EA) 40193489596336 (CS), Lot Numbers: 19ABY900, 19FBT060, 19IBL327, 19PBA051; 10) REF CDS985212B, UDI/DI 10193489779820 (EA) 40193489779821 (CS), Lot Numbers: 19LBU107, 19VBH315, 20BBO078, 20CBW525, 20DBT438, 20GBH006, 20IBN419,
10889942810949, 40889942810940, 10193489552799, 40193489552790, 10198459064548, 40198459064549, 10198459064531, 40198459064532, 10195327561116, 40195327561117, 10889942730407, 40889942730408, 10195327561154, 40195327561155, 10193489592030, 40193489592031, 10193489596335, 40193489596336, 10193489779820, 40193489779821, 10193489823325, 40193489823326, 10889942930296, 40889942930297, 10889942867486, 40889942867487, 10889942868162, 40889942868163, 10195327638283, 40195327638284, 10889942854950, 40889942854951, 10889942854929, 40889942854920, 10195327638450, 40195327638451, 10193489330281, 40193489330282, 10193489345230, 40193489345231
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.