FDA-Device2017-04-19Class II
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
Merit Medical Systems, Inc.
Hazard
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.
Sold states
Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
Affected count
1,940 units total
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1766-2017Don't want to check this manually?
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