Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number: DYNDH1695; 7) DYNDH1708A, Catal
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) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number: DYNDH1695; 7) DYNDH1708A, Catalog Number: DYNDH1708A; 8) DYNDH1714A, Catalog Number: DYNDH1714A; 9) DYNDH1723, Catalog Number: DYNDH1723; 10) DYNDH1740B, Catalog Number: DYNDH1740B; 11) DYNDH1741B, Catalog Number: DYNDH1741B; 12) DYNDH1771A, Catalog Number: DYNDH1771A; 13) DYNDH1908, Catalog Number: DYNDH1908; 14) DYNDH1940, Catalog Number: DYNDH1940; 15) DYNDH1988, Catalog Number: DYNDH1988; 16) DYNDH2002, Catalog Number: DYNDH2002; 17) DYNDH2017, Catalog Number: DYNDH2017. Blood and urine collection kits
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) DYNDB3086DModel UDI-DI: 10195327313234(each)Model 40195327313235(case)Model Lot Number: 24IBA685Model 2) DYNDB3100Model UDI-DI: 10198459028915(each)Model 40198459028916(case)Model Lot Number: 24IBF913Model 3) DYNDH1619AModel UDI-DI: 10195327215835(each)Model 40195327215836(case)Model Lot Number: 24FBH708Model 4) DYNDH1619AModel Lot Number: 24HBG622Model 5) DYNDH1620AModel UDI-DI: 10195327216047(each)Model 40195327216048(case)Model Lot Number: 24GBY827Model 6) DYNDH1620AModel Lot Number: 24HBQ593Model 7) DYNDH1620AUPC 10195327313234UPC 40195327313235UPC 10198459028915UPC 40198459028916UPC 10195327215835UPC 40195327215836UPC 10195327216047UPC 40195327216048UPC 10195327139957UPC 40195327139958UPC 10195327113155UPC 40195327113156UPC 10195327498368UPC 40195327498369UPC 10195327347550UPC 40195327347551Would you have heard about this one?
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