Z-1434-2025 Class II Ongoing
FDA device recall Z-1434-2025 was initiated by Merit Medical Systems, Inc. on January 27, 2025 and is designated Class II. Reason for recall: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. The recall status is ongoing. Affected quantity: 40.
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2025
- Initiation Date
- January 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
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.
Distribution Pattern
International distribution to the country of Japan.
Code Information
UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24