Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0823-2020Class II

Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)

Isopure Corp / initiated 2019-04-19 / Terminated / root cause: manufacturing process

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
FDA enforcement reports joined to recall event Z-0823-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0821-2020Class IITerminatedVoluntary: Firm initiated
Z-0822-2020Class IITerminatedVoluntary: Firm initiated
Z-0823-2020Class IITerminatedVoluntary: Firm initiated