Recall Z-0823-2020— Isopure Corp
Class II · Terminated
Class II FDA medical device recall by Isopure Corp, initiated 2019-04-19, terminated 2020-05-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Isopure Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-19
- Terminated
- 2020-05-29
- Firm location
- Louisville, KY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.