Isopure Centrifugal Pump Recall Due to Magnet Encapsulation Defect
Isopure Corp is recalling eight Finish Thompson Centrifugal Pumps due to a manufacturing defect that could expose magnets to solution, causing corrosion and iron contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential iron contamination) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Isopure Corp is recalling eight units of the Finish Thompson Centrifugal Pump Model #110192-3, which are sold as spare parts. The recall involves specific serial numbers: 178323B18, 178751C18, 178749C18, 180214D18, 180213D18, 180208D18, 178747C18, and 178750C18.
The recall is due to a potential manufacturing defect where the plastic encapsulation of the magnet ring may be uneven, leading to partial axial displacement. This issue could cause uneven wear during use, expose the magnet to the solution, and result in corrosion and the presence of iron.
The affected products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA. Consumers should check their pump serial numbers against the list provided and contact Isopure Corp for instructions on how to proceed.
The recalled product
- Product
- Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
- Manufacturer
- Isopure Corp
- Category
- Medical Device — Pumps
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Pump Serial Numbers: 178323B18
- 178751C18
- 178749C18
- 180214D18
- 180213D18
- 180208D18
- 178747C18
- 178750C18
Distribution
Part of a larger recall action
This product is one of 3 recalled by Isopure Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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