Recall Z-1739-2022 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Isopure Corp
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
| Date | Sep 13, 2022 (initiated Jul 26, 2022) |
| Status | Terminated |
| Reason | Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching |
| Root cause | Device Design |
| Action | 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 fo |
| Quantity | 595 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120005 | ACDS Isopure, Corp., Mar 29, 2012 |