BEUDAMED
    FDA Recall Terminated

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

    Recall: Z-1230-2019 · Initiated January 17, 2017

    Recall

    Recall Number
    Z-1230-2019
    Event Number
    82512
    Firm
    OriGen Biomedical, Inc.
    FEI Number
    1000160256
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 17, 2017
    Posted
    June 4, 2019
    Terminated
    July 27, 2021
    Address
    7000 Burleson Rd, Bldg D, Austin, TX, 78744-3202

    Description

    ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F

    Reason

    Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

    Action

    On 01/17/2017, Technical Bulletin 17.01 was mailed to customers. Customers were informed to clamp all sizes of catheters only in the middle. The following contact information was provided: US: 1-512-474-7278, and Germany: +49-7475-915591.

    Distribution

    US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile

    Quantity

    145