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.
FDA Recall Z-0714-2020 · Posted None
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Recalling FirmAlliance Tech Medical, Inc
Recall StatusCompleted
Product CodeCAH
Date Initiated2014-10-06
Product QuantityApprox. 863/100-unit cases
Reason for Recall
Patients have experienced a bad taste associated with the filters.
Firm 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.
Root Cause
Employee error
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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