Recall Z-1624-2021— Bioseal Corporation

Name: FDA recall Z-1624-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-23

Class II · Completed

Class II FDA medical device recall by Bioseal Corporation, initiated 2021-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096. Reason: 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..

Recalling firm: Bioseal Corporation
Classification: Class II
Status: Completed
Initiated: 2021-03-23
Firm location: Placentia, CA, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.