Louisville, KY, United States
Isopure Corp recalls
3 recalls recorded since 2018, most recently on 26 July 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 July 2022
- Terminated
- 31 May 2024
- Reason
- Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1739-2022
- 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 aci
Ongoing Class II Medical devices
- Recall started
- 28 April 2022
- Reason
- Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring.
- Distribution
- Domestic distribution to AL AZ CO DE FL GA IN KS KY LA MA MD ME MN MO NC NY OK PA TX UT VA WV No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1360-2022
- Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Terminated Class II Medical devices
- Recall started
- 19 April 2019
- Terminated
- 29 May 2020
- Reason
- There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.
- Distribution
- The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0821-2020, Z-0822-2020, Z-0823-2020
- Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
- Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
- Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.