Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72630

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

Open FDA event record

Event summary

Timeline bucket
September 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Valeant Pharmacueticals International

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

Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.

Z-0674-2016
Recall number
Z-0674-2016
Initiated
September 21, 2015
Classification
Class II
Status
Terminated
Quantity
1178

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Finished device change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

Code information

SPAG 2 Unit, Product Part Number 6002

Distribution pattern

USA (nationwide) Distribution and Internationally to Canada and France.