Z-0823-2020 Class II Terminated

Recalled by Isopure Corp — Louisville, KY

FDA device recall Z-0823-2020 was initiated by Isopure Corp on April 19, 2019 and is designated Class II. 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 recall status is terminated (terminated May 29, 2020). Affected quantity: 8.

Recall Details

Product Type
Devices
Report Date
January 29, 2020
Initiation Date
April 19, 2019
Termination Date
May 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8

Product Description

Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)

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 Pattern

The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.

Code Information

Pump Serial Numbers: 178323B18, 178751C18, 178749C18, 180214D18, 180213D18, 180208D18, 178747C18, 178750C18