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Aerial Cushion (2014-02-13)
- Starting date:
- February 13, 2014
- Posting date:
- April 14, 2014
- 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-38995
Recalled Products
Aerial Cushion
Reason
Recent routine internal fire testing to test flammability after multiple washings of the device (N=5) of the whole cushion (cover and foam) in water after 40 degrees celsius, revealed a potential risk of flammability from the product (the "testing failure"). This testing failure contradicts the information contained in the company's instructions for use wherein it states: "hand wash all foam breathair components in warm water at 40 degrees celsius using a standard mild detergent. Do not use fabric softner. Rinse well."
Affected products
Aerial Cushion
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 476C00 = SK701
- 476C00 = SK702
- 476C00 = SK703
- 476C00 = SK704
- 476C00 = SK705
- 476C00 = SK706
- 476C00 = SK707
Companies
- Manufacturer
-
Otto Bock Healthcre
3820 West Great Lakes Dr.
Salt Lake City
84120
Utah
UNITED STATES