Recall Z-0821-2020— Isopure Corp
Class II · Terminated
Class II FDA medical device recall by Isopure Corp, initiated 2019-04-19, terminated 2020-05-29. It names one FDA 510(k) clearance: K120005. Product: Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
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.