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Tracoe experc percut dilation sets
Official notice
1 Dec 2022
Last checked
1 Dec 2022
An official Health Canada notice concerns Tracoe experc percut dilation sets. Tracoe Medical GmbH is issuing a field safety notice for the above products as the application bears a low risk of tearing off the silicone sleeve when removing the insertion system. The incidence rate is 0.016 % and may be further minimized if the application is performed as described in the IFU. Recall start date: October 27, 2022 Published 2022-12-01.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72228
Official notice
2022-12-01
The hazard
The hazard
Tracoe Medical GmbH is issuing a field safety notice for the above products as the application bears a low risk of tearing off the silicone sleeve when removing the insertion system. The incidence rate is 0.016 % and may be further minimized if the application is performed as described in the IFU. Recall start date: October 27, 2022
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Product 2
Product 3
Product 4
Product 5
Product 6
Product 7
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Tracoe Medical, Tracoe Experc Percut Dilation Sets.
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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