Alliance Tech Medical Recalls All Flow Pulmonary Function Filters
Alliance Tech Medical is recalling All Flow Pulmonary Function Filters because patients reported a bad taste associated with the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The reported issue is a bad taste, which is a minor sensory defect rather than a life-threatening hazard, fitting the criteria for a moderate severity recall.
Plain-English summary
Alliance Tech Medical, Inc. is recalling All Flow Pulmonary Function Filters. The affected filters are individually packaged in clear, sealed bags and sold in boxes of 100 for single patient use. The products are latex-free and manufactured in Taiwan.
The recall was initiated because patients have experienced a bad taste associated with the filters. The recall covers approximately 863 100-unit cases. Distribution was made to 23 U.S. states, Puerto Rico, and Canada.
The recall includes two specific lot numbers: lot number 130905 (for all part numbers except 7773100/7773000) and lot number 150102 (for part numbers 7773100/7773000 only). Healthcare facilities and consumers should stop using these filters and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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)…
- Manufacturer
- Alliance Tech Medical, Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Initial recall - lot number 130905 (all part numbers except 7773100/7773000)
- second recall - lot number 150102 (part numbers 7773100/7773000 only).
Distribution
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