Recall Z-1995-2016— FSC Laboratories, Inc

Name: FDA recall Z-1995-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-16

Class II · Terminated

Class II FDA medical device recall by FSC Laboratories, Inc, initiated 2016-05-16, terminated 2017-02-10. It names one FDA 510(k) clearance: K140062. Product: Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).. Reason: Product had torn/loose seal around the mouthpiece..

Recalling firm: FSC Laboratories, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-05-16
Terminated: 2017-02-10
Firm location: Charlotte, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K140062 — FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBERFsc Laboratories, Inc.·cleared 2014-10-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.