The Recall Desk
HighFDA (Devices)·Z-0821-2020·Announced 2020-01-29

Isopure Acidified Concentrate Distribution System Recalled for Magnet Defect

Isopure Corp is recalling 15 Acidified Concentrate Distribution and Storage Systems due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.

What this means for you

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 is classified as FDA Class II, and the hazard involves a risk of harm (corrosion and iron presence) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Isopure Corp is recalling 15 units of the Acidified Concentrate Distribution and Storage System (ACDS System) equipped with a Finish Thompson Centrifugal Pump Model #110192-3. The recall was initiated because of a potential manufacturing defect involving uneven plastic encapsulation of the magnet ring during the molding process.

This defect could lead to partial axial displacement of the magnet, resulting in uneven wear during use. Consequently, the magnet may become exposed to the solution, causing corrosion and the presence of iron in the system. The affected products were distributed to facilities in Alabama, Florida, Georgia, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oklahoma, Texas, and Virginia.

Consumers and facility operators should identify their equipment by checking the ACDS UDI (01)00852456007092) and the specific serial numbers listed in the agency's recall notice. If a unit matches the affected serial numbers, it should be removed from service and the recalling firm contacted for instructions on return or replacement.

The recalled product

Product
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
Manufacturer
Isopure Corp
Category
Medical Device — Dialysis Equipment
Hazard
Affected units
15

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 (16)

  • ACDS UDI: (01)00852456007092
  • ACDS Serial Number AC-837874 with Pump SN 178745C18
  • ACDS Serial Number AC-834638 with Pump SN 180212D18
  • ACDS Serial Number AC-837654 with Pump SN 178324B18
  • ACDS Serial Number AC-837864 with Pump SN 178743C18
  • ACDS Serial Number AC-837664 with Pump SN 178322B18
  • ACDS Serial Number AC-838050 with Pump Serial Number 178752C18
  • ACDS Serial Number AC-838030 with Pump SN 178746C18
  • ACDS Serial Number AC-838020 with Pump SN 178748C18
  • ACDS Serial Number AC-838173 with Pump SN 178744C18
  • ACDS Serial Number AC-838143 with Pump SN 178325B18
  • ACDS Serial Number AC-838260 with Pump SN 180211D18
  • ACDS Serial Number AC-838740 with Pump SN 180209D18
  • ACDS Serial Number AC-838743 with Pump SN 180207D18
  • ACDS Serial Number AC-838749 with Pump SN 180215D18
  • ACDS Serial Number AC-838746 with Pump SN 180206D18

Distribution

Distributed in 13 states:

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.

See all 3 products in this recall →

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