FDA-Device2016-06-22Class II

Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

FSC Laboratories, Inc
Hazard

Product had torn/loose seal around the mouthpiece.

Sold states
US Nationwide distribution.
Affected count
1435 units
Manufactured in
6000 Fairview Rd Ste 600, Charlotte, NC, United States
Products
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1995-2016

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