Recall Z-1623-2021— Bioseal Corporation
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, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177. 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, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
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.