Device product
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
Z-1995-2016
Product summary
- Event
- Event 74197
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1435 units
- Official record key
device-enforcement:Z-1995-2016
Official wording
Reason: Product had torn/loose seal around the mouthpiece.
Code information: Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Product had torn/loose seal around the mouthpiece.