This page has been archived on the Web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.
Cryosurgery System Lm-900 and Frigitronics Cryo-Plus Crysosurgery System (2017-06-30)
- Starting date:
- June 30, 2017
- Posting date:
- July 18, 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-64010
Affected Products
A. Cryosurgery System Lm-900
B. Frigitronics Cryo-Plus Cryosurgery System
Reason
CooperSurgical recently completed validation of a new disinfection procedure and the instructions for use (IFU) for the affected products have been updated. Copies of the updated IFU are being sent to end users. Additionally, CooperSurgical has determined that the useful life of the affected products is 5 years based on a 650 maximum reprocessing cycles.
Affected products
A. Cryosurgery System Lm-900
Lot or serial number
All lots
Model or catalog number
50501
50502
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES
B. Frigitronics Cryo-Plus Cryosurgery System
Lot or serial number
All lots
Model or catalog number
2400
2401
2402
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES