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Bioseal Corporation recalls Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only,
Recalled May 26, 2021 · FDA recall Z-1623-2021 · Bioseal
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. · FDA Class II
Units
140 units
Sold at
US: IL and MO OUS: None
Description
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.
Product
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
Manufacturer(s)
Bioseal Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →