BEUDAMED
    FDA Recall Terminated

    NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-2, 5082-102-2CL , and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112 and 30502-212 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-2, and 635-5084-103-2 - Arden, Skaneateles, NY.

    Recall: Z-753-04 · Initiated March 1, 2004

    Recall

    Recall Number
    Z-753-04
    Event Number
    28428
    Firm
    Welch Allyn Inc
    FEI Number
    1316463
    Product Code
    DXQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2004
    Posted
    July 20, 2004
    Terminated
    September 1, 2005
    Address
    4341 State Street Rd, Skaneateles Falls, NY, 13153-5300

    Description

    NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-2, 5082-102-2CL , and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112 and 30502-212 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-2, and 635-5084-103-2 - Arden, Skaneateles, NY.

    Reason

    GMP deficiencies

    Action

    Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.

    Distribution

    Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.