Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
Medline Industries, LP
The hazard
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) DYKM1414Model UDI-DI: 10889942481293(each)Model 40889942481294(case)Model Lot Number: 24HBS933Model 2) DYNJ38145FModel UDI-DI: 10193489277173(each)Model 40193489277174(case)Model Lot Number: 24HBT600UPC 10889942481293UPC 40889942481294UPC 10193489277173UPC 40193489277174Would you have heard about this one?
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