BEUDAMED
    FDA Recall Terminated

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    Recall: Z-2793-2015 · Initiated August 18, 2015

    Recall

    Recall Number
    Z-2793-2015
    Event Number
    71957
    Firm
    Ecolab Inc
    FEI Number
    1000289767
    Product Code
    LHC
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    August 18, 2015
    Posted
    September 18, 2015
    Terminated
    August 9, 2017
    Address
    370 Wabasha St N, Saint Paul, MN, 55102-1323

    Description

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    Reason

    The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.

    Action

    Consignees were sent on 8/18/2015 an Ecolab "Urgent Medical Device Recall" letter dated August 18, 2015. The letter was addressed to Recall Coordinator or Risk Manager. The letter described the problem and the product involved in the recall. Advised consignees to quarantine all affected lots, and notify their customers of the recall which is to be carried out to users level. Requested consignees to complete and return the enclosed Recall Response Form. For questions they can contact Customer Service at 1-800-824-3027 or e-mail [email protected].

    Distribution

    Worldwide Distribution -- US, including DC and PR; and, the countries of SAUDI ARABIA, LEBANON, GERMANY, HONG KONG, SINGAPORE, CANADA, and JAPAN.

    Quantity

    5,172,816 units