FDAFDA · Food and drugs·Recall number Z-1624-2021
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Published May 26, 2021 · Recall initiated: March 23, 2021
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bioseal Corporation
- Distributor
- US: IL and MO OUS: None
- Lot
- Affected Lot Numbers: 400521, 400514, 400551, 400556, 400551, 400541, 400536, 400536, 400536 400536, 400536, 400556, 400558
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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