Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Reported: April 2, 2025 Initiated: January 27, 2025 #Z-1434-2025
Product Description
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Reason for Recall
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 40
- Distribution
- International distribution to the country of Japan.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D. Recalled by Merit Medical Systems, Inc.. Units affected: 40.
Why was this product recalled? ▼
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2025. Severity: Moderate. Recall number: Z-1434-2025.
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