Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Reported: May 26, 2021 Initiated: March 23, 2021 #Z-1624-2021
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.
Details
- Recalling Firm
- Bioseal Corporation
- Units Affected
- 580 units
- Distribution
- US: IL and MO OUS: None
- Location
- Placentia, CA
Frequently Asked Questions
What product was recalled? ▼
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096. Recalled by Bioseal Corporation. Units affected: 580 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 26, 2021. Severity: Moderate. Recall number: Z-1624-2021.
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