This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
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-64404
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