—#212497

Product

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K173750
Affected lot / code info: UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24

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.

Root cause (FDA determination)

Packaging process control

Action the firm took

On 1/27/2025, recall notices were sent to customers asking them to do the following: 1) Quarantine, and discontinue use and distribution of affected devices. 2) Return all affected lots in your possession to the recalling firm. 3) Ensure that applicable personnel within your organization are made aware of this field action. 4) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Questions can be directed to Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: International distribution to the country of Japan.

Timeline

Recall initiated: 2025-01-27
Posted by FDA: 2025-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212497. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.