FDA-Device2021-05-26Class II
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
Bioseal Corporation
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.
Sold states
US: IL and MO OUS: None
Affected count
140 units
Manufactured in
167 W Orangethorpe Ave, N/A, Placentia, CA, United States
Products
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1623-2021Don't want to check this manually?
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