Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A; 5) DYNDB3061, Catalog Number: DYNDB3061; 6) DYNDH1245, Catalog Number: DYNDH1245; 7) DYNDH1362, Catalog
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) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A; 5) DYNDB3061, Catalog Number: DYNDB3061; 6) DYNDH1245, Catalog Number: DYNDH1245; 7) DYNDH1362, Catalog Number: DYNDH1362
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) ACC010308AModel UDI-DI: 10889942424597(each)Model 40889942424598(case)Model Lot Number: 24HDA993Model 2) ACC010308AModel Lot Number: 24IDB285Model 3) ACC010308AModel Lot Number: 24JDA212Model 4) ACC010374AModel UDI-DI: 10193489893977(each)Model 40193489893978(case)Model Lot Number: 24IDB849Model 5) ACC010679Model UDI-DI: 10195327396268(each)Model 40195327396269(case)Model Lot Number: 24HDA071Model 6) ACC010726AModel UDI-DI: 10198459043666(each)Model 40198459043667(case)Model Lot Number: 24GDB143Model 7) DYNDB3061UPC 10889942424597UPC 40889942424598UPC 10193489893977UPC 40193489893978UPC 10195327396268UPC 40195327396269UPC 10198459043666UPC 40198459043667UPC 10889942143733UPC 40889942143734UPC 10889942604722UPC 40889942604723UPC 10888277797086UPC 40888277797087Would you have heard about this one?
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