Exact FDA event identifier

Event 74197

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: May 16, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: FSC Laboratories, Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1995-2016

Recall number: Z-1995-2016
Initiated: May 16, 2016
Classification: Class II
Status: Terminated
Recalling firm: FSC Laboratories, Inc
Quantity: 1435 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product had torn/loose seal around the mouthpiece.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product had torn/loose seal around the mouthpiece.

Code information

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

Distribution pattern

US Nationwide distribution.