BEUDAMED
    FDA Recall Terminated

    Portex 1st Response Adult Manual Resuscitators Ref: 8500P

    Recall: Z-0809-03 · Initiated November 15, 2002

    Recall

    Recall Number
    Z-0809-03
    Event Number
    25083
    Firm
    Sims Portex Inc.
    FEI Number
    1217052
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 15, 2002
    Posted
    May 22, 2003
    Terminated
    May 11, 2004
    Address
    10 Bowman Drive, Keene, NH, 03431

    Description

    Portex 1st Response Adult Manual Resuscitators Ref: 8500P

    Reason

    Peep valve set at the highest level and could result in patient injury

    Action

    Portex notiifed direct customers by telephone (medical facilities and distributors) on 11/15/2002 and 11/18/2002 inforrming them to isolate and hold inventory. A letter dated 11/19/02 issued by Fed''X to return product or remove/discard PEEP valve from unit and complete the response form.

    Distribution

    Nationwide. AL, CA, CO, IA, IL, FL, GA, LA, KS, KY, MA, ME, MN, MO, MS, NC,NM, NY, OK, SC, TN, TX, WA WY, UT, VA

    Quantity

    2976