Gambro Renal Products Inc: Medical Device Recall in 2014 - (Recall #: Z-0489-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 5, 2014

Date Posted: December 10, 2014

Recall Number: Z-0489-2015

Event ID: 69786

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.

Status: Terminated

Product Quantity: 20 million dialyzers

Code Information:

Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001

Distribution Pattern:

Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.

Voluntary or Mandated:

Voluntary: Firm initiated