Health product recall

Prelude Roadster Guide Sheath

Last updated

Summary

Product
Prelude Roadster Guide Sheath
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Prelude Roadster Guide Sheath

H2817178
H2800643

PG5F45S018
PG6F45S018

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Merit Medical Systems Inc.

1600 West Merit Parkway, South Jordan, Utah, United States, 84095

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75360

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