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Ezdilate™ balloon dilator (wg)
Official notice
25 Sept 2024
Last checked
25 Sept 2024
An official Health Canada notice concerns Ezdilate™ balloon dilator (wg). Olympus is taking this recall action after having received 4 complaints between March 2024 and June 2024 from customers indicating the balloon was packaged with the incorrect Glo cath label applied to the balloon dilation catheter for the diameter sizes. The incorrect label states 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm. All other labeling is correct for the balloon, including the shelf box with front box label and circular star label and the balloon pouch. Recall start date: September 13, 2024 Published 2024-09-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76204
Official notice
2024-09-25
The hazard
The hazard
Olympus is taking this recall action after having received 4 complaints between March 2024 and June 2024 from customers indicating the balloon was packaged with the incorrect Glo cath label applied to the balloon dilation catheter for the diameter sizes. The incorrect label states 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm. All other labeling is correct for the balloon, including the shelf box with front box label and circular star label and the balloon pouch. Recall start date: September 13, 2024
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Gyrus Acmi, Ezdilate™ Balloon Dilator.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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Ezdilate balloon dilators
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