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Health product recall

POLYFLUX REVACLEAR

Starting date:
October 6, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-60550

Affected Products

Reason

Baxter Corporation is issuing a voluntary product recall for one (1) lot of REVACLEAR Max Dialyzers due to the potential presence of particulate matter within the blood side of the dialyzer. The issue was identified as a result of one customer complaint received for the presence of black fibers and dust within the dialyzer.

There is the potential of visually not detecting the presence of foreign material in the blood side of the dialyzer. When the dialyzer is used, the particles may become dislodged by flow of the dialysate and may reach the vascular system of the patient, which could lead to adverse health consequences. There have been no reports of injuries associated with this issue.

Affected products

POLYFLUX REVACLEAR

Lot or serial number

C416201601

Model or catalog number

110634

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