Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
Check against the official notice below — it lists the full affected range.
Isopure Corp is recalling one Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3 due to a potential defect in the magnet ring's plastic encapsulation. During the molding process, the magnet ring may not have been evenly encapsulated and could be partially displaced, which could cause uneven wear during use and expose the magnet to the solution, potentially resulting in corrosion and the presence of iron.
The affected product was distributed to customers in Alabama, Florida, Georgia, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oklahoma, Texas, and Virginia. The specific product involved has an IsoMix Pro UDI of (01)00852456007085, an ISOMIX Serial Number of IMP-838703, and a Pump Serial Number of 180210D18. The recall record does not specify what remedy consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Quantity: 1 Lot/code info: IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.