Z-0949-2017Class II

PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is...

Name: Z-0949-2017 PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is...
Creator: Merit Medical Systems, Inc.
Published: 2016-12-01
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2016-12-01 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the... on 2016-12-01. FDA classified it as Class II and gives the reason as "Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0949-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-01
Posted: 2017-01-05
Terminated: 2017-04-18
Recalling firm: Merit Medical Systems, Inc.
Product: PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires
Product code: DYB Introducer, Catheter
Reason for recall: Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Merit Medical sent an Urgent Product Recall Notice dated December 1, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify any affected devices within their facility, quarantine them, and discontinue use. Ensure that all personnel to whom the devices were distributed are made aware of this field action. Consignees were asked to work with their Merit Sales Representative to arrange product return. Consignees with questions were instructed to contact their Merit Sales Representative or Merit Customer Service at [email protected] or at 801-208-4381. For questions regarding this recall call 801-208-4623.
Quantity in commerce: 335
Distribution: Nationwide Distribution
Product codes and lots: Lots: H1014678, H1039272, H1029150, H1039269, H1029151

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0949-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0949-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-05

Product code DYB

K140543Class IIPreludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. / cleared 2014-10-16

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)