Prelude Roadster Guide Sheath
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
---|---|---|
Prelude Roadster Guide Sheath |
H2817178 |
PG5F45S018 |
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
Merit Medical Systems Inc.
1600 West Merit Parkway, South Jordan, Utah, United States, 84095
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