Prelude recallZ-3190-2024 · Merit Medical Systems, Inc. · initiated Aug 12, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
7F sheath introducers labeled as 7.5F
FDA root cause category: Labeling mix-ups
What the company is doing
On 8/12/24, recall notices were mailed or emailed to customers who were asked to do the following: 1) Determine if any of the products identified in the attached Customer Response From (CRF) are within your facility. 2) Ensure that appropriate personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4) Post this "URGENT MEDICAL DEVICE RECALL NOTICE" on or near the affected products. Product may continue to be used once this recall notice is placed on or near them. 5) Complete and return the response form via email to [email protected] If you have any questions concerning this communication, contact the firm's Sales Representative or Customer Service at +1 800 356 3748 | Hours: 6 am to 6 pm MST, Mon-Fri.
Recall details
- Recall number
- Z-3190-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 12, 2024
- Posted by the FDA
- Sep 20, 2024
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1892
- Product code
- DRE
- FDA submissions
- K070159
- Distribution
- Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.
Product description
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Code information (models, lots, serial numbers)
REF/UDI-DI/Lot (Expiration Date): PSI-7F-11-038 Version F/00884450708835/H2874685 (09-Mar-2027), H2878374 (26-FEB-2027), H2904232 (11-MAY-2027)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Prelude® FMerit Medical Systems, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95234).
- Z-3191-2024 · Open, ClassifiedCustom Procedure Kit, REF: K12T-11077
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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