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Leisegang and Frigitronics Cryosurgery System (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:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56048
Affected Products
- Leisegang LM-900 Cryosurgery System
- Frigitronics Cryo-Plus Cryosurgery System
Reason
CooperSurgical is advising all Leisegang LM-900 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. Leisegang LM-900 Cryosurgery System
Lot or serial number
All lots.
Model or catalog number
- 50501
- 50502
Companies
- Manufacturer
-
COOPERSURGICAL INC.
95 Corporate Drive
Trumbull
06611
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
UNITED STATES