Reported Apr 2, 2025 · Ongoing
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
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 IDEAL 4 F Hydrophilic Sheath Introducer
- REFPID4F16021PW/D
- Lot codes and dates
- UDI-DI00884450693919
- LotH3082668
- Expiration14-Nov-24
- Amount recalled
- 40
Why it was recalled
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
This product could cause temporary or reversible health problems — stop using it.
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