BEUDAMED
    FDA Enforcement Class II Terminated

    Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

    Recall: Z-0013-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0013-2019
    Event ID
    80924
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    COVIDIEN LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    August 1, 2018
    Classification Date
    October 2, 2018
    Termination Date
    June 3, 2020
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113, United States

    Description

    Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.

    Reason

    Potential for product sterility breach due to a compromised or pinched seal defect

    Code Info

    Lot Numbers: 18D180962,18D181062,18E029462,18E029562,18E070762, 18E131262,18E131362,18E131462,18E166662,18E167362, 18E223462,18E223362,18F054362,18E222662,18F034762, 18F034662,18F035562,18F072862,18F072662,18F072962, 18F123062,18F122562,18F122662

    Distribution

    US Nationwide Distribution

    Quantity

    2,730,821 units in total