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Blendox AII5000F - Inhalation Antalgic System (July 05, 2013)
- Starting date:
- July 05, 2013
- Posting date:
- July 05, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-35065
Reason
Ambulance received one hospital report of oxygen backflow through a device into the nitrous oxide source line which caused gas line contamination. No injury or potential hazard to patients resulted through the incident. Company's investigation has identified the root cause and corrective and preventative actions have been determined. Although there are no evidence suggesting the same problem will occur with the other units sold in Canada, company is initiating this action as a precautionary measure.
Affected products
Blendox AII5000F - Inhalation Antalgic System (2013-07-05)
Lot or serial number
AII5000F00651E - AII5000F00731E, AII5000F00611E - AII5000F00642E
Model or catalog number
Not applicable
Companies
- Manufacturer
- Not Applicable
- Date modified: