CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
All Flow Pulmonary Function Filters, 100 filters individually recalled
Alliance Tech Medical is recalling Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually, distributed in 24 states. The recall was initiated on 6 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0714-2020
- FDA event ID
- 83830
- Recalling firm
- Alliance Tech Medical, Granbury, TX
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 6 Oct 2014
- FDA classified
- 19 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 6 Oct 2014 | Recall initiated by company | |
| 19 Dec 2019 | Classified by FDA | +1900 days |
| 25 Dec 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Patients have experienced a bad taste associated with the filters.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMissouriMississippiNorth CarolinaNew JerseyNew YorkOhioPuerto Rico
Questions about this recall
Is All Flow Pulmonary Function Filters, 100 filters individually recalled?
Yes. Alliance Tech Medical recalled All Flow Pulmonary Function Filters, 100 filters individually on 6 Oct 2014. The recall is Class II and its status is Completed. Recall number Z-0714-2020.
Why was it recalled?
Patients have experienced a bad taste associated with the filters.
Which lots are affected?
Initial recall - lot number 130905 (all part numbers except 7773100/7773000); second recall - lot number 150102 (part numbers 7773100/7773000 only).
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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