Product Wiki · Recalls · Health Canada — Medical Devices

THERMACHOICE THERMAL BALLOON CATHETER (2015-12-01) — recall 54207

Health Canada — Medical Devices · Canada · 2015-12-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54207
Date of alert
2015-12-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/thermachoice-thermal-balloon-c

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