Z-0714-2020Class II

Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a...

Name: Z-0714-2020 Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a...
Creator: Alliance Tech Medical, Inc
Published: 2014-10-06
License: https://open.fda.gov/license/

Alliance Tech Medical, Inc / initiated 2014-10-06 / Completed / root cause: manufacturing process

FDA source

Alliance Tech Medical, Inc began a recall of Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100... on 2014-10-06. FDA classified it as Class II and gives the reason as "Patients have experienced a bad taste associated with the filters". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0714-2020
Classification: Class II
Status: Completed
Initiated: 2014-10-06
Posted: 2019-12-19
Recalling firm: Alliance Tech Medical, Inc
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.
Product code: CAH Filter, Bacterial, Breathing-Circuit
Reason for recall: Patients have experienced a bad taste associated with the filters.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: Approx. 863/100-unit cases
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.
Product codes and lots: Initial recall - lot number 130905 (all part numbers except 7773100/7773000); second recall - lot number 150102 (part numbers 7773100/7773000 only).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0714-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0714-2020	Class II	Completed	Voluntary: Firm initiated	2019-12-25	2019-12-19

Product code CAH

K043148Class IIAll Flow Pulmonary Function FilterAlliance Tech Medical, Inc. / cleared 2004-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)