BEUDAMED
    FDA Enforcement Class II Ongoing

    White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.

    Recall: Z-2101-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2101-2017
    Event ID
    77063
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medical Action Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    April 19, 2017
    Classification Date
    May 17, 2017
    Address
    25 Heywood Rd, Arden, NC, 28704-9302, United States

    Description

    White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.

    Reason

    Lint present on sterile Operating Room Towels.

    Code Info

    Material Number: MSPT524, Lot #229445, Exp. Date: 10/12/2021.

    Distribution

    AR, IN and NV.

    Quantity

    69 cases