FSC Laboratories, Inc recalls Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from…
- Recall date
- May 16, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1995-2016
- FDA classification
- Class II
- Brand / firm
- FSC Laboratories, Inc
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Product had torn/loose seal around the mouthpiece.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
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