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Revolve System
- Starting date:
- August 8, 2017
- Posting date:
- September 5, 2017
- 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-64424
Reason
This recall has been initiated due to the presence of bacterial endotoxins levels for some revolve units are above the acceptable limits as defined in the standard, USP ("medical devices - bacterial endotoxin and pyrogen tests"). The issue was self identified/confirmed on May 4, 2017.161>
Affected products
Revolve System
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
RV0001
RV0002
RV0004
Companies
- Manufacturer
-
LIFECELL CORPORATION
#1 MILLENNIUM WAY
BRANCHBURG
08876-3876
New Jersey
UNITED STATES