Z-1956-2020Class II

Custom Sheath Introducer Kit REF K21-00031 -

Name: Z-1956-2020 Custom Sheath Introducer Kit REF K21-00031 -
Creator: Merit Medical Systems, Inc.
Published: 2019-09-12
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2019-09-12 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices... on 2019-09-12. FDA classified it as Class II and gives the reason as "labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit...". 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-1956-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-12
Posted: 2020-05-11
Terminated: 2022-05-27
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Product code: DYB Introducer, Catheter
Reason for recall: labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A verbal (telephone) notification attempt was made to the customer on September 12th and 13th. These attempts resulted in a voicemail informing the customer of a voluntary product recall and requesting a call back. A hospital employee was reached by telephone on September 17, 2019 and notified of the product recall. The notification included product identification information, instruction to immediately quarantine any devices and to discontinue use and to return product to Merit per the instructions contained in the Customer Response Form (CRF). The CRF and details of the recall were emailed to the hospital per customer request.. Merit Medical Systems, Inc. is conducting a recall of the K21-00031 Custom Prelude IDeal Kit, lot number H1583914, due to the kit including a Prelude EASE sheath assembly rather than the labeled Prelude IDeal sheath assembly. Additionally, the kit has a labeling error in which the unit and carton labeling indicate a 6 French color (green) rather than the correct 4 French color (red). Merit Medical has not received any complaints from customers or any reports of patient harm or injury as a result of this issue. Return the affected products to Merit via Federal Express 2nd Day Air (Acct# 112952756), include the assigned RMA number. Send to Field Assurance Department Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 Attn: RMA# (found in contact information table) For further information contact Merit Customer service at (801) 208-4381 or by email at [email protected].
Quantity in commerce: 15 kits
Distribution: US Nationwide distribution in the state of MI.
Product codes and lots: Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1956-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1956-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11

Product code DYB

K173750Class IIPrelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. / cleared 2018-02-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)