FDA Medical Device Recalls (openFDA)
FSC Laboratories, Inc: Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
- Recall number
- Z-1995-2016
- Recalling firm
- FSC Laboratories, Inc
- Product
- Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
- Status
- Terminated
- Initiated
- 2016-05-16
- Posted
- 2016-06-15
- Terminated
- 2017-02-10
- Reason
- Product had torn/loose seal around the mouthpiece.
- Root cause
- Process control
- Action
- Letters were sent to consignees on 5/16/2016 informing them of the recall and requesting that they immediately discontinue use of the product. The letter included a reply form to be returned to FSC Laboratories.
- Quantity
- 1435 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01
- 510(k) numbers
- ["K140062"]
- PMA numbers
- not on file
- Product code
- NVP
- Firm FEI
- 3008832322
- Firm city
- Charlotte
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28