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Terminated

Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

FDA Recall Z-1995-2016 · Posted 2016-06-15

Recalling FirmFSC Laboratories, Inc
Recall StatusTerminated
Product CodeNVP
Date Initiated2016-05-16
Date Terminated2017-02-10
Product Quantity1435 units

Reason for Recall

Product had torn/loose seal around the mouthpiece.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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