Reported Jun 22, 2016 · Terminated

Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from…

FSC Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: FSC Laboratories, Inc · 6000 Fairview Rd Ste 600 · Charlotte, NC · 28210-2201

Is this the product you have?

  • Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
Lot codes and dates
  • Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01
Amount recalled
1435 units

Where it was sold

  • Nationwide

Why it was recalled

Product had torn/loose seal around the mouthpiece.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 10, 2017 · Data as of Sep 19, 5:59 PM UTC

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