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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 1) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24IBA685; 2) DYNDB3100, UDI-DI: 10198459028915(each), 40198459028916(case), Lot Number: 24IBF913; 3) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24FBH708; 4) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24HBG622; 5) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24GBY827; 6) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24HBQ593; 7) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24HBU881; 8) DYNDH1694A, UDI-DI: 10195327139957(each), 40195327139958(case), Lot Number: 24EBI901; 9) DYNDH1694A, UDI-DI: 10195327139957(each), 40195327139958(case), Lot Number: 24HBG834; 10) DYNDH1695, UDI-DI: 10195327113155(each), 40195327113156(case), Lot Number: 24FBQ907; 11) DYNDH1708A, UDI-DI: 10195327498368(each), 40195327498369(case), Lot Number: 24IBQ580; 12) DYNDH1714A, UDI-DI: 10195327347550(each), 40195327347551(case), Lot Number: 24EBI892; 13) DYNDH1714A, UDI-DI: 10195327347550(each), 40195327347551(case), Lot Number: 24IBE380; 14) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24EBI893; 15) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24GBH135; 16) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24HBG826; 17) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24EBV834; 18) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24FBH710; 19) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24FBK197; 20) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24GBW340; 21) DYNDH1741B, UDI-DI: 10198459006319(each), 40198459006310(case), Lot Number: 24FBJ622; 22) DYNDH1741B, UDI-DI: 10198459006319(each), 40198459006310(case), Lot Number: 24GBW330; 23) DYNDH1771A, UDI-DI: 10198459088971(each), 40198459088972(case), Lot Number: 24IBJ998; 24) DYNDH1908, UDI-DI: 10195327472467(each), 40195327472468(case), Lot Number: 24EBC055; 25) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24FMH509; 26) DYNDH1988, UDI-DI: 10195327628772(each), 40195327628773(case), Lot Number: 24HBF080; 27) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24GBO301; 28) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24HBQ827; 29) DYNDH2017, UDI-DI: 10198459022159(each), 40198459022150(case), Lot Number: 24HBO219
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.