Recall Z-0714-2020— Alliance Tech Medical, Inc

Name: FDA recall Z-0714-2020
Creator: U.S. Food and Drug Administration
Published: 2014-10-06

Class II · Completed

Class II FDA medical device recall by Alliance Tech Medical, Inc, initiated 2014-10-06. It names one FDA 510(k) clearance: K043148. 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: Patients have experienced a bad taste associated with the filters..

Recalling firm: Alliance Tech Medical, Inc
Classification: Class II
Status: Completed
Initiated: 2014-10-06
Firm location: Granbury, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K043148 — ALL FLOW PULMONARY FUNCTION FILTERAlliance Tech Medical, Inc.·cleared 2004-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

Patients have experienced a bad taste associated with the filters.

Data sourced from openFDA. This site is unofficial and independent of the FDA.