Health product recall

Polyflux Revaclear Max Dialyzer (2017-12-15)

Starting date:
December 15, 2017
Posting date:
September 7, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67678

Affected products

Polyflux Revaclear Max Dialyzer

Reason

Baxter Corporation is issuing a voluntary product recall for one lot of Revaclear MAX Dialyzer, due to the potential of a small number of Revaclear MAX Dialyzers being labelled as Revaclear MAX Dialyzers.

Affected products

Polyflux Revaclear Max Dialyzer

Lot or serial number

C416224101

Model or catalog number

110634

Companies
Manufacturer
Gambro Renal Products Inc - Opelika Facility,
1101 Jeter Avenue
Opelika
36801
Alabama
UNITED STATES