BEUDAMED
    FDA Enforcement Class II 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 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0714-2020
    Event ID
    83830
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Alliance Tech Medical, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2019
    Initiation Date
    October 6, 2014
    Classification Date
    December 19, 2019
    Address
    4053 Acton Hwy Ste 103, Granbury, TX, 76049-6131, United States

    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.

    Code Info

    Initial recall - lot number 130905 (all part numbers except 7773100/7773000); second recall - lot number 150102 (part numbers 7773100/7773000 only).

    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