CUSA Clarity Console C7000 Operators Manual (2019-10-21)
- Starting date:
- October 21, 2019
- Posting date:
- April 15, 2020
- 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-72709
Last updated: 2020-04-15
Affected Products
CUSA Clarity Console C7000 Operators Manual
Reason
It was discovered through internal review that we need to revise the operator's manual to reflect the most accurate sterilization parameters and hence the dry time parameters have been changed from 30 minutes to 40 minutes for the CUSA Clarity 36khz handpiece and components consistent with the CUSA Clarity 23khz handpiece and components.
Affected products
CUSA Clarity Console C7000 Operators Manual
Lot or serial number
All lots.
Model or catalog number
C7000
Companies
- Manufacturer
-
Integra Lifesciences (Ireland) Ltd.
Ida Business and Technology Park
Sragh, Tullamore, Offaly
IRELAND