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Isodan(2015-06-16)
- Starting date:
- June 16, 2015
- Posting date:
- August 24, 2015
- 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-54510
Affected Products
A. Isodan
Reason
Septodont currently distributes this device in Canada as a class 1 medical device. Health Canada has advised Septodont that this product should be classified as a class 2 medical device. All products in the field will therefore be recalled and all commercial sales stopped until the product is licensed appropriately
Affected products
A. Isodan
Lot or serial number
>10 contact manufacturer
Model or catalog number
P00377
Companies
- Manufacturer
-
Septodont
58 Rue du Pont de Creteil
St-Maur-Des-Fosses
94107
FRANCE