FDA Device recall Z-0371-2016
Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicat…
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicat… by Valeant Pharmaceuticals North America, citing SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0371-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-14 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | AL, AZ, CA, CO, IL, MO, NC, NY, OH, PA, SC, TX, UT |
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
Reason
SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
Identifiers
| code_info | Lot #J3522070 Serial numbers 23461 23463 23466 23467 23468 23469 23472 23475 23477 23479 23480 23481 23…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0371-2016%22
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