Events

Recall of Device Recall Flexichamber AntiStatic Valved Collapsible Holding Chamber

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by FSC Laboratories, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74197
  • Event Risk Class
    Class 2
  • Event Number
    Z-1995-2016
  • Event Initiated Date
    2016-05-16
  • Event Date Posted
    2016-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146711
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Holding chambers, direct patient interface - Product Code NVP
  • Reason
    Product had torn/loose seal around the mouthpiece.
  • 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.

Device

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

Manufacturer

FSC Laboratories, Inc
  • Manufacturer Address
    FSC Laboratories, Inc, 6000 Fairview Rd Ste 600, Charlotte NC 28210-2201
  • Source
    USFDA