Recall Z-0674-2016

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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

FDA-determined cause: Finished device change control

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.