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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