Recall Z-1766-2017— Merit Medical Systems, Inc.

Name: FDA recall Z-1766-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-03

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2017-03-03, terminated 2017-06-21. It names one FDA 510(k) clearance: K162988. Product: The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.. Reason: Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Terminated: 2017-06-21
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K162988 — PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc.·cleared 2017-01-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.

Reason for recall

Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.

Data sourced from openFDA. This site is unofficial and independent of the FDA.