Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
Isopure Corp began a recall of Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part) on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0823-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Isopure Corp
- Product
- Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
- Product code
- N/A
- 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.
- Root cause tag
- manufacturing process
- FDA 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 in commerce
- 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.
- Product codes and lots
- Pump Serial Numbers: 178323B18, 178751C18, 178749C18, 180214D18, 180213D18, 180208D18, 178747C18, 178750C18
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0821-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0822-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0823-2020 | Class II | Terminated | Voluntary: Firm initiated |
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