BEUDAMED
    FDA Enforcement Class II Completed

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

    Recall: Z-1624-2021 · Reported May 26, 2021

    Enforcement

    Recall Number
    Z-1624-2021
    Event ID
    87636
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Bioseal Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 26, 2021
    Initiation Date
    March 23, 2021
    Classification Date
    May 20, 2021
    Address
    167 W Orangethorpe Ave, N/A, Placentia, CA, 92870-6922, United States

    Description

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

    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.

    Code Info

    Affected Lot Numbers: 400521, 400514, 400551, 400556, 400551, 400541, 400536, 400536, 400536 400536, 400536, 400556, 400558

    Distribution

    US: IL and MO OUS: None

    Quantity

    580 units