FDA Medical Device Recalls (openFDA)
Gambro Renal Products Inc: Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
- Recall number
- Z-0490-2015
- Recalling firm
- Gambro Renal Products Inc
- Product
- Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
- Status
- Terminated
- Initiated
- 2014-11-05
- Posted
- 2014-12-01
- Terminated
- 2015-05-20
- Reason
- Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
- Root cause
- Process control
- Action
- Recall letter was sent via UPS delivery next day to US customers on November 5th, 2014. Product that is returned will be quarantined at the distribution centers.
- Quantity
- 20 million dialyzers
- Distribution
- Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
- Lot, serial or model codes
- Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3006552611
- Firm city
- Opelika
- Firm state
- AL
- 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