Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
Check against the official notice below — it lists the full affected range.
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.
Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 447 kits Lot/code info: 1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24HBS933; 2) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24HBT600
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.