Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A ne

FDA device recall Z-0674-2016 · posted 2016-01-21 · Terminated

Recall details

Recalling firm

Valeant Pharmacueticals International

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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

Action taken

Valeant Pharmaceuticals International, Inc. sent Field Correction Notifications /Recall Stock Response Form dated September 22, 2015 through 2nd day air service to their customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. T The customers were requested to fill out and return the attached Recall Stock Response Form and return the form via email (bauschandlomb6443@stericycle.com or fax (844.782.5565). A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576) On October 7, 2015 a second field correction notification was sent to customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576). The updated notification clarified that the notification applies to all SPAG-2 6000 model units currently in the market.

Root cause

Finished device change control

Status

Terminated

Product code

CAF

Quantity affected

1178

Distribution

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

Date initiated

2015-09-21

Date posted

2016-01-21

Date terminated

2017-05-19

Location

Bridgewater, NJ

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