Isopure Recalls
5 recalls on record · January 29, 2020 to September 21, 2022 · Medical Devices
Recalls by year
20
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 21, 2022Medical DevicesFDA
Isopure Corp recalls Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with re
Hazard: Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
July 20, 2022Medical DevicesFDA
Isopure Corp recalls Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Hazard: 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.
January 29, 2020Medical DevicesFDA
Isopure Corp recalls Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
Hazard: 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.
January 29, 2020Medical DevicesFDA
Isopure Corp recalls Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #11
Hazard: 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.
January 29, 2020Medical DevicesFDA
Isopure Corp recalls Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #11019
Hazard: 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.