FDAMarch 3, 2017device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
merit medical systemsmeritmerit medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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