Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Reason for recall: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. Quantity: 793,785 total units Lot/code info: 1) CHIP99SP11, UDI-DI:10195594137595 (each) 50195594137593 (case), Lot Number: 5138229 ; 2) CHIP99SP12, UDI-DI:10195594268466 (each) 50195594268464 (case), Lot Number: 5324036 ; 3) CHIP99SP13, UDI-DI:10197106271377 (each) 50197106271375 (case), Lot Number: 6907769 ; 4) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7045815 ; 5) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280043 ; 6) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701891 ; 7) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701938 ; 8) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6986974 ; 9) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7005449 ; 10) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7055825 ; 11) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7160425 ; 12) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7260062 ; 13) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280062 ; 14) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7287465 ; 15) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6485588 ; 16) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7331290 ; 17) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), L
10195594137595, 50195594137593, 10195594268466, 50195594268464, 10197106271377, 50197106271375, 10888439373226, 50888439373224, 10195594006723, 50195594006721, 10195594158040, 50195594158048, 10195594307745, 50195594307743, 10888439373219, 50888439373217, 10197106544402, 50197106544400, 10195594301002, 50195594301000, 10195594592653, 50195594592651, 10195594632403, 50195594632401, 10195594728694, 50195594728692, 10197106531891, 50197106531899, 10197106567555, 50197106567553, 10195594936990, 50195594936998, 10195594708320, 50195594708328, 10197106429112, 50197106429110, 10197106682050, 50197106682058, 10197106717301, 50197106717309
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.