Class 2 Device Recall

• Date Initiated by Firm: August 12, 2024
• Date Posted: September 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3190-2024
• Recall Event ID: 95234
• 510(K)Number: K070159
• Product Classification: Dilator, vessel, for percutaneous catheterization - Product Code DRE
• Product: Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
• Code Information: 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)
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-253-1600
• Manufacturer Reason for Recall: 7F sheath introducers labeled as 7.5F
• FDA Determined Cause: Labeling mix-ups
• Action: 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 response@merit.com 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.
• Quantity in Commerce: 1892
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DRE