Recall Z-0822-2020 ยท FIN Tank, Holding, Dialysis
Isopure Corp
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
| Date | Jan 19, 2020 (initiated Apr 19, 2019) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 1 |
| Distribution | The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM Isopure, Corp., Jan 26, 2012 |