Z-3190-2024Class II

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

Name: Z-3190-2024 Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Creator: Merit Medical Systems, Inc.
Published: 2024-08-12
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2024-08-12 / Open, Classified / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) on 2024-08-12. FDA classified it as Class II and gives the reason as "7F sheath introducers labeled as 7.5F". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3190-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-12
Posted: 2024-09-20
Recalling firm: Merit Medical Systems, Inc.
Product: Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: 7F sheath introducers labeled as 7.5F
Root cause tag: labeling and UDI
FDA root 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 [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.
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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3190-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3190-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3191-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20

Product code DRE

K070159Class IIPrelude Sheath IntroducerMerit Medical Systems, Inc. / cleared 2007-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)