FDA recall Z-0714-2020

Alliance Tech Medical, Inc · Class II · device

Product

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 for recall

Patients have experienced a bad taste associated with the filters.

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.

Key facts

Status
Completed
Initiation date
2014-10-06
Report date
2019-12-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Granbury, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0714-2020