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Polyflux Revaclear Dialyzers (2014-11-12)
- Starting date:
- November 12, 2014
- Posting date:
- November 21, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-42231
Recalled products
- Polyflux Revaclear Dialyzers
Reason
There is a possibility of a tear in the individual packaging on some Polyflux Revaclear / Polyflux Revaclear Max Dialyzers. This was noticed during internal inspection and it is possible that the packaging on distributed product could also be impacted.
Affected products
A. Polyflux Revaclear Dialyzers
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 110633
- 110634
Companies
- Manufacturer
-
Gambro Renal Products Inc - Opelika Facility,
1101 Jeter Avenue,
Opelika
36801
Alabama
UNITED STATES