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: 205360 units Lot/code info: 1) REF CDS780162AA, UDI/DI 10193489262049 (EA) 40193489262040 (CS), Lot Numbers: 20BBO888, 20BBQ352, 20FBR735; 2) REF CDS780162AB, UDI/DI 10193489338447 (EA) 40193489338448 (CS), Lot Numbers: 20GBF853; 3) REF CDS780162AC, UDI/DI 10193489383911 (EA) 40193489383912 (CS), Lot Numbers: 20HBE537, 20IBB263, 20JBB811, 20KBA268, 20LBM232, 21ABA833; 4) REF CDS780162AD, UDI/DI 10193489498950 (EA) 40193489498951 (CS), Lot Numbers: 21ABU170, 21BBQ045, 21DBD059, 21DBS617, 21GBS609, 21HBB525; 5) REF CDS780162X, UDI/DI 10889942840281 (EA) 40889942840282 (CS), Lot Numbers: 19ABX591, 19BBM085, 19CBM932, 19EBF768, 19EBU016, 19EBY613, 19FBI652, 19GBV765; 6) REF CDS780162Y, UDI/DI 10193489694079 (EA) 40193489694070 (CS), Lot Numbers: 19HBC545, 19HBD425, 19JBG849, 19LBO181, 19RBB546, 19VBH579; 7) REF CDS780208F, UDI/DI 10193489494211 (EA) 40193489494212 (CS), Lot Numbers: 21FBD429, 22ABH903, 22BBQ627, 22DBL468, 22EBM543, 22HBH464, 22IBN540, 22KBM775, 23ABM574, 23ABU440; 8) REF CDS981327N, UDI/DI 10889942959273 (EA) 40889942959274 (CS), Lot Numbers: 19ABN030, 19DBH383, 19EBJ379, 19GBI961, 19HBU954, 19JBK986, 19LBW564, 20CBH905, 20EBS213, 20GBU395; 9) REF CDS981327O, UDI/DI 10193489396782 (EA) 40193489396783 (CS), Lot Numbers: 20JBO709, 20LBM343, 20LBM792, 21CBE183, 21DBJ732; 10) REF CDS981327P, UDI/DI 10193489930825 (EA) 40193489930826 (CS), Lot Numbers: 21KBO532, 22ABE609; 11) REF CDS981327Q, UDI/DI 10195327080365 (EA) 40195327080366 (CS), Lot Numbers: 22BMC351, 22BMG728, 22FMF883, 22FMH830, 22GM
10193489262049, 40193489262040, 10193489338447, 40193489338448, 10193489383911, 40193489383912, 10193489498950, 40193489498951, 10889942840281, 40889942840282, 10193489694079, 40193489694070, 10193489494211, 40193489494212, 10889942959273, 40889942959274, 10193489396782, 40193489396783, 10193489930825, 40193489930826, 10195327080365, 40195327080366, 10193489463668, 40193489463669, 10889942654956, 40889942654957, 10193489919790, 40193489919791, 10195327457969, 40195327457960, 10889942730575, 40889942730576, 10889942727056, 40889942727057, 10889942724970, 40889942724971, 10195327173944, 40195327173945, 10889942688616, 40889942688617
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.