Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching

Isopure initiated contact via telephone on 7/26/22 followed by Emails to consignees. .Letter states reason for recall, health risk and action to take: 1. Refer to Distribution List of ACDS units installed. 2. Perform an inspection of the ACDS device, associated wiring, cabling and cord. Provide a photograph if damage is found during inspection. 3. Video links are included in the inspection packet of the Isopure ACDS Instructions for Electrical Review and Preventive Maintenance of the ACDS and proper use of a torque screwdriver as a guide to inspecting electrical connections WI-50602. Please follow these guidance documents. Adhere to all safety information provided. 4. Fill out the Acknowledgement and Inspection Form upon completion of the inspection. Return the Acknowledgment form back to Isopure to [email protected] by September 30, 2022. 5. Always replace any depleted or blown fuses with the correct type and correct rating. 6. Follow the recommended preventive maintenance schedule for the device (refer to LA704262 ACDS Acidified Concentrate Distribution and Storage System User Manual). 7. Contact Isopure Customer/Technical Support at 502-967-7873 with any questions or concerns. Refer to: How -To-Video- Instructions ACDS Preventive Maintenance Instructions https://vimeo.com/732224767