This page has been archived on the Web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.
SARNS Modular Perfusion System 8000
- Starting date:
- March 9, 2017
- Posting date:
- March 31, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62846
Reason
Terumo Cardiovascular Systems (Terumo CVS) has determined that level sensor II pads product labels have the expiration date displayed in a format that may not be recognizable to all users. These products are used with Terumo Advanced Perfusion System 1 and SARNS Modular Perfusion System 8000 heart-lung machines. The issue was identified via internal investigation, and there have been no related user complaints. Terumo CVS is providing directions on how to read the expiration date on affected products.
Affected products
SARNS Modular Perfusion System 8000
Lot or serial number
782300 through 817488
Model or catalog number
195240
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
Michigan
UNITED STATES