FDA Recall
Terminated
Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
Recall: Z-0823-2020
·
Initiated April 19, 2019
Recall
- Recall Number
- Z-0823-2020
- Event Number
- 83990
- Firm
- Isopure Corp
- FEI Number
- 3013942511
- Product Code
- N/A
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 19, 2019
- Posted
- January 19, 2020
- Terminated
- May 29, 2020
- Address
- 11851 Plantside Dr, Louisville, KY, 40299-6328
Description
Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
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.
Action
The only affected customer was contacted via telephone on 4/19/19. An URGENT PRODUCT FIELD CORRECTION NOTICE dated 5/22/19 was distributed to affected clinics.
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
8