Bioseal Corporation recalls Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only,…

Recall date

March 23, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1624-2021

FDA classification

Class II

Brand / firm

Bioseal Corporation

Sold / distributed

US: IL and MO OUS: None

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096