Recall Z-0823-2020 ยท N/A
Isopure Corp
Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
| 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 | 8 |
| 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
This recall record lists no 510(k) number.