Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are si
FDA device recall Z-0490-2015 · posted 2014-12-01 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 20 million dialyzers
- Distribution
- Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
- Date initiated
- 2014-11-05
- Date posted
- 2014-12-01
- Date terminated
- 2015-05-20
- Location
- Opelika, AL
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