Reported Jul 3, 2024 · Ongoing
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- Prelude Roadster Guide Sheath REF-PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP -PG7F45MPX -PG7F45RX -PG7F45S -PG7F45SX -PG7F65SX -PG7F90SX -PG8F45MPX -PG8F45S -PG8F45SX -PG8F65SX -PG8F90SX -X9PG700001 The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature
- Lot codes and dates
- Catalog Code/Lot Number/UDI-DINote - 23 additional lot Numbers added on 06/14/2024
1,077 of 1,077 codes
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
- Catalog Code/Lot Number/UDI-DI
- Amount recalled
- 52,410 (updated 06/14/2024)
Where it was sold
Why it was recalled
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
This product could cause temporary or reversible health problems — stop using it.
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