FDA Medical Device Recalls (openFDA)
Isopure Corp: Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
- Recall number
- Z-0821-2020
- Recalling firm
- Isopure Corp
- Product
- Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
- Status
- Terminated
- Initiated
- 2019-04-19
- Posted
- 2020-01-19
- Terminated
- 2020-05-29
- 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
- 15
- Distribution
- The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K120005"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3013942511
- Firm city
- Louisville
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28