FDAClass IIJune 22, 2016

Flexichamber Anti-Static Valved Collapsible Holding recall

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

Why was Flexichamber Anti-Static Valved Collapsible Holding recalled?

Product had torn/loose seal around the mouthpiece.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01

Product
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose…
Recalling firm
FSC Laboratories, Inc
Quantity
1435 units
Distribution
US Nationwide distribution.
Recall date
June 22, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls