—#180571

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.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K173750
Affected lot / code info: Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 response@merit.com.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: US Nationwide distribution in the state of MI.

Timeline

Recall initiated: 2019-09-12
Terminated: 2022-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.