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
- Recall Initiated
- September 14, 2015
- Posted
- December 4, 2015
- Terminated
- June 27, 2017
- Recall Number
- Z-0371-2016
- Quantity
- 61 units
- Firm Location
- Bridgewater, NJ
Reason for Recall
SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
Distribution
AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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.