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THERMACHOICE THERMAL BALLOON CATHETER (2015-12-01)
- Starting date:
- December 1, 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-56312
Affected Products
THERMACHOICE THERMAL BALLOON CATHETER
Reason
Ethicon Inc. has initiated a recall of all unexpired lots of the GYNECARE THERMACHOICE III Thermal Balloon Ablation Silicone Catheter because stability data does not substantiate the labeled two-year shelf life of the affected product. The recall involves only the catheter component of the GYNECARE THERMACHOICE III Uterine Balloon Therapy System.
Affected products
THERMACHOICE THERMAL BALLOON CATHETER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- TC033
- TC043
Companies
- Manufacturer
-
Ethicon Inc.
Rt. 22 West, P.O. Box 151
Sommerville
08876
New Jersey
UNITED STATES