KIT PEDI CRANI LAMI, Pack Number DYNJ907372A

Reason: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.

Code information: UDI/DI Case 40195327060412, UDI/DI Each 10195327060411; Lot Numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, 22ALA325

Distribution pattern: US: TX, IL, CA