Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,

Hazard

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Details from the source

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: 973,785 total units Lot/code info: 1) PWV2MF104, UDI-DI:10888439676167 (each) 50888439676165 (case), Lot Number: J46C10 ; 2) PWV2MF105, UDI-DI:10195594004217 (each) 50195594004215 (case), Lot Number: J8998R ; 3) PWV2MF106, UDI-DI:10195594095994 (each) 50195594095992 (case), Lot Number: 5136000 ; 4) PWV2MF107, UDI-DI:10195594148065 (each) 50195594148063 (case), Lot Number: 5140389 ; 5) PWV2MF108, UDI-DI:10195594228941 (each) 50195594228949 (case), Lot Number: 5140389 ; 6) PWV2MF109, UDI-DI:10195594394875 (each) 50195594394873 (case), Lot Number: J65K18 ; 7) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: HP1027 ; 8) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4220A ; 9) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J43W15 ; 10) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4953C ; 11) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6022K ; 12) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J6372Z ; 13) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J7708T ; 14) PWV2MF10W, UDI-DI:10888439693645 (each) 50888439693643 (case), Lot Number: J8241D ; 15) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K11 ; 16) PWV2MF10Y, UDI-DI:10888439967432 (each) 50888439967430 (case), Lot Number: J84K10 ; 17) PWV2MF10Z, UDI-DI:10195594180294 (each) 50195594180292 (case), Lot Number: J65K19 ; 18) PWV2MF

UPC codes

10888439676167, 50888439676165, 10195594004217, 50195594004215, 10195594095994, 50195594095992, 10195594148065, 50195594148063, 10195594228941, 50195594228949, 10195594394875, 50195594394873, 10888439342741, 50888439342749, 10888439693645, 50888439693643, 10888439967432, 50888439967430, 10195594180294, 50195594180292, 10195594634957, 50195594634955, 10195594711177, 50195594711175, 10197106368718, 50197106368716, 10197106738399, 50197106738397, 10197106784167, 50197106784165, 10197106143469, 50197106143467, 10197106245491, 50197106245499, 10197106425701, 50197106425709, 10197106484340, 50197106484348, 10197106532461, 50197106532469

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.