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Ambu AuraGain (2015-12-09)
- Starting date:
- December 9, 2015
- Posting date:
- January 22, 2016
- 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-56758
Affected Products
Ambu AuraGain
Reason
Lack of sterility assurance. A manufacturing issue may cause a small hole (approximately 0.5 mm) in the AuraGain pouch and potentially compromise the sterile barrier. A leak in the sterile barrier may allow contamination of the device with the risk of causing an infection, which may require an antibiotic treatment.
Affected products
Ambu AuraGain
Lot or serial number
More than 1000 numbers, contact manufacturer
Model or catalog number
408 300 000
408 400 000
408 500 000
Companies
- Manufacturer
-
Ambu A/S
BALTORPBAKKEN 13
BALLERUP
DENMARK