Z-1995-2016 Class II Terminated
FDA device recall Z-1995-2016 was initiated by FSC Laboratories, Inc on May 16, 2016 and is designated Class II. Reason for recall: Product had torn/loose seal around the mouthpiece. The recall status is terminated (terminated February 10, 2017). Affected quantity: 1435 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2016
- Initiation Date
- May 16, 2016
- Termination Date
- February 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1435 units
Product Description
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
Reason for Recall
Product had torn/loose seal around the mouthpiece.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01