FDA Medical Device Recalls (openFDA)
Gambro Renal Products Inc: Polyflux Revaclear Dialyzer, Model Number 110633. 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-0489-2015
- Recalling firm
- Gambro Renal Products Inc
- Product
- Polyflux Revaclear Dialyzer, Model Number 110633. 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. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
- 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