Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bioseal Recalled by Bioseal Corporation Due to Pre-op skin prep component ChloraPrep included within kits...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bioseal Corporation directly.
Affected Products
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Quantity: 580 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 2 states: IL, MO
About Bioseal Corporation
Bioseal Corporation has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report