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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00121-1
Product Name/Description	Hypothermia Caps, Mittens and Slippers Product Name: Hypothermia Cap Product Number: cap-610 Batch Number: 052016C Product Name: Hypothermia Slippers Product Number: SL3000 Batch Number: 041116D Product Name: Hypothermia Mitts Product Number: TM7008 Batch Number: 042016C ARTG Number: 272254 (cancelled)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/02/2018
Responsible Entity	Control Medics Pty Ltd
Reason/Issue	The manufacturer, Southwest Technologies are recalling all Hypothermia products including Caps, Mittens and Slippers for the intended use of reduction of chemotherapy induced alopecia, onycholysis and skin toxicity. The devices are misbranded for use during chemotherapy treatments, and may lead to frostbite to digits on patients with, but not limited to diabetic neuropathy, Raynaud's disease, Distal metastasis, Distal arteriopathy and cold intolerance. There have been reports of serious injuries overseas as a result of this issue.
Recall Action	Recall
Recall Action Instructions	Control Medics is advising customers to discontinue use of affected products immediately. Customers are advised to quarantine all affected stock to prevent further use and return it to Control Medics. This action has been closed out on 23/01/2019
Contact Information	07 3216 2311 - Customer Service Support