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Bioseal Corporation recalls Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094
Recalled May 26, 2021 · FDA recall Z-1622-2021 · Bioseal
Hazard
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. · FDA Class II
Units
1,560 units
Sold at
US: IL and MO OUS: None
Description
Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
Product
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Manufacturer(s)
Bioseal Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →