Z-1826-2015Class II

Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit...

Name: Z-1826-2015 Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit...
Creator: Merit Medical Systems, Inc.
Published: 2015-06-04
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2015-06-04 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access... on 2015-06-04. FDA classified it as Class II and gives the reason as "Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1826-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-06-22
Terminated: 2015-10-26
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Merit Medical sent an Urgent Product Recall letter on June 4, 2015, to all affected consignees. Consignees were instructed to immediately quarantine any affected devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative. An email notification was sent to Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account and a representative copy of communications sent directly to their affected accounts. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department. Customers with questions were instructed to contact their Merit Sales Representative or call (801) 208-4365.
Quantity in commerce: 1,445
Distribution: Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.
Product codes and lots: Catalo Number PR0-6F-11-038, Lot Number H767887

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1826-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1826-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)