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: 3903 units Lot/code info: 1) REF DYNJ0660040R, UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Numbers: 19BKB772, 19DKB804, 19FKB661, 19GKD118, 19IKA148, 19KKB086, 20AKB057, 20BKB114, 20FKB215, 20JKA546, 20LMA968, 20LMF795, 21DMA309, 21DMF310, 21FMA264, 21GMB043, 21HMD757, 21JMC608, 21KMH631, 22CMB438; 2) REF DYNJ42833A, UDI/DI 10888277503991 (EA) 40888277503992 (CS), Lot Numbers: 19ABS779, 19EBZ888, 19FBJ253, 19FBO513, 19FBX305, 19GBF427, 19LBY431, 20CBD972, 20DBV565, 20HBL275, 20LBA473, 20LBG895, 21CBI208; 3) REF DYNJ42833B, UDI/DI 10193489880335 (EA) 40193489880336 (CS), Lot Numbers: 21GBJ447, 21GBJ449, 21HBM834, 21HBR207, 22CBT921, 22DBM124, 22GBD852, 22HBF050, 22HBJ420, 22IBJ529, 22KBR876, 23BBA545, 23CBD715, 23CBQ582, 23DBH453, 23HBE012, 23HBR165, 23IBK906, 23KBP817, 24BBA648, 24DBD590, 24FBI859, 24GBU033, 24IBG868, 24JBI576; 4) REF DYNJ50692C, UDI/DI 10193489752199 (EA) 40193489752190 (CS), Lot Numbers: 19KDA566, 20BDC412, 20CDA575, 20GMD317, 21DMA002; 5) REF DYNJ54736B, UDI/DI 10889942925483 (EA) 40889942925484 (CS), Lot Numbers: 19ABB603, 19ABV222, 19CBN379, 19DBS122, 19EBZ894, 19FBQ049; 6) REF DYNJ82735, UDI/DI 10195327207540 (EA) 40195327207541 (CS), Lot Numbers: 22KMF252, 23EMG596, 23FMA429, 23IMA461, 23JMC236, 24BMC071; 7) REF DYNJ903144C, UDI/DI 10193489677881 (EA) 40193489677882 (CS), Lot Numbers: 19JBK003, 19SBD201, 20ABZ780, 20FBK295, 20GBR819, 20IBH005, 20LBK729, 20LBL461, 20LBO417, 20LBU129, 22AMA090, 22AMC790, 22BMF138, 22EMH876; 8) REF DYNJ905365A, UDI/DI 10193489759037 (EA) 4
10889942220083, 40889942220084, 10888277503991, 40888277503992, 10193489880335, 40193489880336, 10193489752199, 40193489752190, 10889942925483, 40889942925484, 10195327207540, 40195327207541, 10193489677881, 40193489677882, 10193489759037, 40193489759038, 10193489750492, 40193489750493, 10193489344721, 40193489344722, 10193489890006, 40193489890007, 10193489913187, 40193489913188, 10195327020118, 40195327020119
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.