BEUDAMED
    FDA Enforcement Class II Ongoing

    Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.

    Recall: Z-2102-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2102-2017
    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

    Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 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: AVID260, Lot #231253, Exp. Date: 10/31/2021 (48 pk) and Material Number: MSPT504, Lot #229259, Exp. Date: 10/12/2021 (20 pk).

    Distribution

    AR, IN and NV.

    Quantity

    38 cases (3-48pk/35-20pk)