Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with re

FDA device recall Z-1739-2022 · posted 2022-09-13 · Terminated

Recall details

Recalling firm

Isopure Corp

Reason for recall

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

Action taken

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 Quality@isopure.com 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

Root cause

Device Design

Status

Terminated

Product code

KPO

Quantity affected

595 units

Distribution

US Nationwide distribution.

Date initiated

2022-07-26

Date posted

2022-09-13

Date terminated

2024-05-31

Location

Louisville, KY

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