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: 48655 units Lot/code info: 1) REF CDS981185B, UDI/DI 10884389647141 (EA) 40884389647142 (CS), Lot Numbers: 19CDB151, 19DDD096, 19FDA612, 19IDA540, 19LDB150, 20BDA647, 20DDB481, 20IDA733, 20LDA459; 2) REF CDS983087G, UDI/DI 10193489237351 (EA) 40193489237352 (CS), Lot Numbers: 21LBS976; 3) REF CDS983302G, UDI/DI 10888277753181 (EA) 40888277753182 (CS), Lot Numbers: 19JDB741; 4) REF CDS983302I, UDI/DI 10193489425659 (EA) 40193489425650 (CS), Lot Numbers: 23FDA273, 23IDA781; 5) REF CDS983483G, UDI/DI 10889942946068 (EA) 40889942946069 (CS), Lot Numbers: 19CDB914, 19DDB938, 19GDB412, 19GDC427, 19JDA647, 19KDB084, 19LDC222, 20BDC250, 20EDB879, 20GDC001, 20JDA007, 20JDB542, 20LDB199; 6) REF CDS983483I, UDI/DI 10193489919585 (EA) 40193489919586 (CS), Lot Numbers: 21FDB817, 21HDA571, 21KDB608, 22BDA109; 7) REF CDS984313G, UDI/DI 10193489540437 (EA) 40193489540438 (CS), Lot Numbers: 19GBL203, 20EBC321, 20KBB606; 8) REF DYNJ0101278F, UDI/DI 10193489352351 (EA) 40193489352352 (CS), Lot Numbers: 20FDA999, 20HDA734, 20KDB838, 21ADC024, 21CDA355, 21EDA527, 21GDC529, 21IDA040, 21IDA786, 21JDB214, 21KDC443, 22ADC117, 22CDB133; 9) REF DYNJ0826316K, UDI/DI 10889942092642 (EA) 40889942092643 (CS), Lot Numbers: 19FKB533, 19EKD537; 10) REF DYNJ0826316L, UDI/DI 10193489413496 (EA) 40193489413497 (CS), Lot Numbers: 21IME029, 21IMC729, 20IKB206; 11) REF DYNJ0867411F, UDI/DI 10889942620579 (EA) 40889942620570 (CS), Lot Numbers: 19EDA018; 12) REF DYNJ10130D, UDI/DI 10193489432176 (EA) 40193489432177 (CS), Lot Numbers: 21BBC490,
10884389647141, 40884389647142, 10193489237351, 40193489237352, 10888277753181, 40888277753182, 10193489425659, 40193489425650, 10889942946068, 40889942946069, 10193489919585, 40193489919586, 10193489540437, 40193489540438, 10193489352351, 40193489352352, 10889942092642, 40889942092643, 10193489413496, 40193489413497, 10889942620579, 40889942620570, 10193489432176, 40193489432177, 10889942389209, 40889942389200, 10889942450121, 40889942450122, 10193489317794, 40193489317795, 10193489849677, 40193489849678, 10195327595272, 40195327595273, 10889942465255, 40889942465256, 10888277585720, 40888277585721, 10888277208711, 40888277208712
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.