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Prelude roadster guide sheath
Official notice
8 Apr 2024
Last checked
8 Apr 2024
An official Health Canada notice concerns Prelude roadster guide sheath. Merit Medical Systems, Inc. Is voluntarily conducting a recall of the Prelude Roadster Guide Sheath due to an incorrect dilator included with the product. This is limited to sheaths labeled with .018" dilators, which may contain .038" dilators. This affects two lots. Merit has not received any reports of patient harm or injury relating to this issue; however, Merit has received one complaint relating to this issue. Use of the incorrect dilator may result in procedure delay or soft tissue injury. Recall Start Date: March 14, 2024 Published 2024-04-08.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75360
Official notice
2024-04-08
The hazard
The hazard
Merit Medical Systems, Inc. Is voluntarily conducting a recall of the Prelude Roadster Guide Sheath due to an incorrect dilator included with the product. This is limited to sheaths labeled with .018" dilators, which may contain .038" dilators. This affects two lots. Merit has not received any reports of patient harm or injury relating to this issue; however, Merit has received one complaint relating to this issue. Use of the incorrect dilator may result in procedure delay or soft tissue injury. Recall Start Date: March 14, 2024
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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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: Merit Medical, Prelude Roadster Guide Sheath.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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