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Wallach Cryosurgery and Cryosurgical Systems (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-64020
Affected Products
A. Wallach Ll100 Cryosurgery System-Wa1000 System-A
B. Wallach Ll100 Cryosurgery System-Ll100/Ll50x
C. Wallach Ll100 Cryosurgery System-Wa1000b Console System
D. Wallach LL100 Cryosurgery System-WA1000B Console System With Timer/Temp Indicator
E. Wallach Ll-Co2 Multi-Tip Cryosurgical System
F. Wallach Llco2 Cryosurgery System-Wa1000b Cryosurgical Console
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. Wallach Ll100 Cryosurgery System-Wa1000 System-A
Lot or serial number
All lots
Model or catalog number
900502-4
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES
B. Wallach Ll100 Cryosurgery System-Ll100/Ll50x
Lot or serial number
All lots
Model or catalog number
900001
900002
900020
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES
C. Wallach Ll100 Cryosurgery System-Wa1000b Console System
Lot or serial number
All lots
Model or catalog number
900001A-NO2
900506-1-N2O
900506-2-N2O
900630
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES
D. Wallach LL100 Cryosurgery System-WA1000B Console System With Timer/Temp Indicator
Lot or serial number
All lots
Model or catalog number
900629
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES
E. Wallach Ll-Co2 Multi-Tip Cryosurgical System
Lot or serial number
All lots
Model or catalog number
900150
900162
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES
F. Wallach Llco2 Cryosurgery System-Wa1000b Cryosurgical Console
Lot or serial number
All lots
Model or catalog number
900506-2-CO2
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES