FDA recall Z-1739-2022

Product

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2022-07-26

Report date

2022-09-21

Termination date

2024-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1739-2022