FSC Laboratories, Inc: Medical Device Recall in 2016 - (Recall #: Z-1995-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 16, 2016

Date Posted: June 22, 2016

Recall Number: Z-1995-2016

Event ID: 74197

Reason for Recall:

Product had torn/loose seal around the mouthpiece.

Status: Terminated

Product Quantity: 1435 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated