Z-1995-2016Class II

Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized...

Name: Z-1995-2016 Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized...
Creator: FSC Laboratories, Inc
Published: 2016-05-16
License: https://open.fda.gov/license/

Fsc Laboratories, Inc. / initiated 2016-05-16 / Terminated / root cause: manufacturing process

FDA source

FSC Laboratories, Inc began a recall of Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose... on 2016-05-16. FDA classified it as Class II and gives the reason as "Product had torn/loose seal around the mouthpiece". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1995-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-16
Posted: 2016-06-15
Terminated: 2017-02-10
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).
Product code: NVP Holding Chambers, Direct Patient Interface
Reason for recall: Product had torn/loose seal around the mouthpiece.
Root cause tag: manufacturing process
FDA 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 in commerce: 1435 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1995-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1995-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-15

Product code NVP

K140062Class IIFsc Anti-Static Valved Collapsible Holding ChamberFsc Laboratories, Inc. / cleared 2014-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)