BEUDAMED
    FDA Enforcement Class II Terminated

    Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.

    Recall: Z-2744-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2744-2016
    Event ID
    74710
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ecolab Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2016
    Initiation Date
    July 14, 2016
    Classification Date
    September 7, 2016
    Termination Date
    November 2, 2016
    Address
    370 Wabasha St N, Saint Paul, MN, 55102-1323, United States

    Description

    Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.

    Reason

    Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.

    Code Info

    RBA202 Lot numbers: D111574, D111654, D111724, D111864, D112024, D112094, D112224, D120164, D120454, D120544, D121144, D121314, D121674, D121944, D122204, D122554, D122854, D123324, D130354, D130454, D130914, D131704, D131994, D132464, D132974, D140834, D141204, D141774, D142244, D150404, D151334, D151464, D152304, D152364, D152454, D153084, D153204, D153494, D160544. RBA203 Lot numbers: D122194, D122354

    Distribution

    US: OH, NY, CA, MN.

    Quantity

    6750 eaches (675 cases)