BEUDAMED
    FDA Recall Completed

    Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.

    Recall: Z-0714-2020 · Initiated October 6, 2014

    Recall

    Recall Number
    Z-0714-2020
    Event Number
    83830
    Firm
    Alliance Tech Medical, Inc
    FEI Number
    3004476631
    Product Code
    CAH
    Status
    Completed
    Root Cause
    Employee error
    Initiated
    October 6, 2014
    Address
    4053 Acton Hwy, Ste 103, Granbury, TX, 76049-6131

    Description

    Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.

    Reason

    Patients have experienced a bad taste associated with the filters.

    Action

    The first recall was initiated via first class mail on/about 10/6/2014 via an undated letter. The second recall was initiated approximately 8/27/2015 via phone.

    Distribution

    Distribution was made to AL, AR, AZ, CA, CO, DE, FL, GA, IL, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, TN, TX, WA, and WY. There was also distribution to Puerto Rico. Foreign distribution was made to Canada.

    Quantity

    Approx. 863/100-unit cases