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Blanketrol III Model 233 Hyper-Hypothermia Devices (2013-09-03)
- Starting date:
- September 3, 2013
- Posting date:
- October 28, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36427
Recalled Products
Blanketrol III Model 233 Hyper-Hypothermia Devices
Reason
A field action has been initiated due to changes that have been made to the blanketrol III model 233 device's operation and operation/technical service manuals in order to stay in compliance with labeling regulations. The changes include clarification in identifying the product's indications for use to remove unintended clinical applications.
Affected products
Blanketrol III Model 233 Hyper-Hypothermia Devices
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 233
Companies
- Manufacturer
-
Cincinnati Sub-Zero Products
12011 Mosteller Road
Cincinnati
45241
Ohio
UNITED STATES