BEUDAMED
    FDA Recall Terminated

    NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); Firm on label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corporation, McGaw Park, IL 60085-6787 USA''

    Recall: Z-0244-04 · Initiated October 27, 2003

    Recall

    Recall Number
    Z-0244-04
    Event Number
    27522
    Firm
    Welch Allyn Inc
    FEI Number
    1316463
    Product Code
    DXQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 27, 2003
    Posted
    December 18, 2003
    Terminated
    September 1, 2005
    Address
    4341 State Street Rd, Skaneateles Falls, NY, 13153-5300

    Description

    NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); Firm on label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corporation, McGaw Park, IL 60085-6787 USA''

    Reason

    Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.

    Action

    Letters dated October 27, 2003 to wholesalers/ distributors with instructions to remove/return product and notify end users.

    Distribution

    The product was sold thru 11 distributors. The product was shipped to end users nationwide. There is one foreign distributor in Singapore. In addition, Welch Allyn shipped product to their affiliates in Ireland, Australia, and South Africa.

    Quantity

    26190