Bioseal Corporation recalls Bioseal, Central Line Dressing Kit, containing ChloraPREP Ap
Recalled Product
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Hazard / Issue
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.
Issued by
FDA
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