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U.S. Department of Health and Human Services

Medical Devices

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Merit Medical Systems Prelude Short Sheath Catheter Introducer

Recall Class: Class I

Date Recall Initiated: December 17, 2010

Product(s): Prelude Short Sheath Introducer, 7F-SMT, 4cm, reference number PSS-7F-4-038MT, Sterile EO, Merit, lot/serial number H179575.

378 devices are subject to this recall.

The Company notified sales representatives and authorized distributors on Dec. 17, 2010 by email, phone and fax to immediately contact customers to identify, quarantine and return all unused inventory. In addition, distributors were instructed to extend the recall to any of their customers who may have received the affected products.

Reason for Recall: Introducer tips may detach during use causing arterial injury, hemorrhaging, or other serious events, while introducer tip material may enter into the bloodstream causing blood clots (thrombosis).

Use: The Merit Prelude Short Sheath Catheter Introducer is used to provide access and facilitate the introduction of other medical devices into veins or arteries while maintaining hemostasis for a variety of procedures.

Recalling Firm:

Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095

Public Contact:

Merit Medical Systems, Inc. at 1-801-316-4932, or 1-800-356-3748. 8am to 5pm Mon-Fri MST.

FDA District: Denver

FDA Comments:

Merit Medical Systems, Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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