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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72198

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

Open FDA event record

Event summary

Timeline bucket
September 14, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Valeant Pharmaceuticals North America LLC

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 Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole

Z-0371-2016
Recall number
Z-0371-2016
Initiated
September 14, 2015
Classification
Class II
Status
Terminated
Quantity
61 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.

Code information

Lot #J3522070 Serial numbers 23461 23463 23466 23467 23468 23469 23472 23475 23477 23479 23480 23481 23482 23484 23485 23486 23487 23488 23489 23490 23491 23492 23493 23495 23503 23504 23505 23506 23507 23508 23509 23510 23512 23513 23514 23515 23517 23520 23521 23524 23529 23530 23531 23532 23535 23536 23540 23547 23558 23560 23568 23569 23570 23571 23572 23579 23587 23589 23590 23592 23593

Distribution pattern

AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX