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Solus Flexible Laryngeal Mask Airway
- Starting date:
- March 28, 2017
- Posting date:
- June 5, 2017
- 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-63484
Reason
A manufacturing fault in the tube supplied to intersurgical for production of the device can result in partial or total occlusion of the airway tube when the cuff is inflated, which may result in partial or total restriction of air delivery to and/or from the patient.
Affected products
Solus Flexible Laryngeal Mask Airway
Lot or serial number
31310139 to 31703855
Model or catalog number
8002001
8003001
8004001
8005001
8025001
Companies
- Manufacturer
-
Intersurgical Ltd.
Crane House, Molly Millars Lane, Wokingham, Berkshire
Great Britain
RG41 2RZ
UNITED KINGDOM