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Bioseal Corporation FDA Recalls

3 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094Class IIMar 23, 2021Pre-op skin prep component ChloraPrep included within kits m
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, Class IIMar 23, 2021Pre-op skin prep component ChloraPrep included within kits m
Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, Class IIMar 23, 2021Pre-op skin prep component ChloraPrep included within kits m

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