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Wallach Cryosurgery Systems (2015-11-12)
- Starting date:
- November 12, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-56098
Affected Products
- Wallach LL100 Cryosurgery System (WA3000)
- Wallach LL100 Cryosurgery System
- Wallach LL100 Cryosurgery System (WA1000B)
- Wallach LL100 Cryosurgery System (Multi Tip)
- Wallach LLCO2 Cryosurgery System
- Wallach LLCO2 Cryosurgery System (WA1000B)
Reason
CooperSurgical is advising all Wallach LL100 Cryosugery System users that there are questions regarding the validity of the current high level disinfection procedure for the shaft of the system's hand piece. This notification does not include any cryosurgical tips which currently have a validated high level disinfection procedure. Therefore, CooperSurgical is advising all customers of record to practice all necessary diligence when using the device.
Affected products
A. Wallach LL100 Cryosurgery System (WA3000)
Lot or serial number
All lots.
Model or catalog number
- 900502-4
Companies
- Manufacturer
-
COOPERSURGICAL INC.
95 Corporate Drive
Trumbull
06611
UNITED STATES
B. Wallach LL100 Cryosurgery System
Lot or serial number
All lots.
Model or catalog number
900001
900002
900020
Companies
- Manufacturer
-
COOPERSURGICAL INC.
95 Corporate Drive
Trumbull
06611
UNITED STATES
C. Wallach LL100 Cryosurgery System (WA1000B)
Lot or serial number
All lots.
Model or catalog number
900001A-NO2
900150
900506-1-N2O
900506-2-N2O
900630
Companies
- Manufacturer
-
COOPERSURGICAL INC.
95 Corporate Drive
Trumbull
06611
UNITED STATES
D. Wallach LL100 Cryosurgery System (Multi Tip)
Lot or serial number
All lots.
Model or catalog number
900629
Companies
- Manufacturer
-
COOPERSURGICAL INC.
95 Corporate Drive
Trumbull
06611
UNITED STATES
E. Wallach LLCO2 Cryosurgery System
Lot or serial number
All lots.
Model or catalog number
900150
900162
Companies
- Manufacturer
-
COOPERSURGICAL INC.
95 Corporate Drive
Trumbull
06611
UNITED STATES
F. Wallach LLCO2 Cryosurgery System (WA1000B)
Lot or serial number
All lots.
Model or catalog number
900506-2-CO2
Companies
- Manufacturer
-
COOPERSURGICAL INC.
95 Corporate Drive
Trumbull
06611
UNITED STATES