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Devices
Device Recall Flexichamber AntiStatic Valved Collapsible Holding Chamber
Model / Serial
Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide distribution.
Product Description
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
Manufacturer
FSC Laboratories, Inc
1 Event
Recall of Device Recall Flexichamber AntiStatic Valved Collapsible Holding Chamber
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Manufacturer
FSC Laboratories, Inc
Manufacturer Address
FSC Laboratories, Inc, 6000 Fairview Rd Ste 600, Charlotte NC 28210-2201
Source
USFDA
Language
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