Z-0371-2016Class II

Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a...

Name: Z-0371-2016 Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a...
Creator: Valeant Pharmaceuticals North America LLC
Published: 2015-09-14
License: https://open.fda.gov/license/

Valeant Pharmaceuticals North America LLC / initiated 2015-09-14 / Terminated

FDA source

Valeant Pharmaceuticals North America LLC began a recall of Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the... on 2015-09-14. FDA classified it as Class II and gives the reason as "SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0371-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Posted: 2015-12-04
Terminated: 2017-06-27
Recalling firm: Valeant Pharmaceuticals North America LLC
Product: 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
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
FDA root cause: Under Investigation by firm
Action: Valeant Pharmaceuticals International issued recall letter/return response form dated 9/11/2015 via 2nd day air service Customers were requested to check their inventory for the SPAG-2 device and sgregate it for return shipment.
Quantity in commerce: 61 units
Distribution: AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0371-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0371-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04

Product code CAF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)