Reported Apr 19, 2017 · Terminated
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- 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.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published SRB24ACLot Numbers: H1068590S1, H1078177, H1078180, H1083628 SRB24MEDLot Numbers: H1068587S1,H1073974, H1078179, H1078181, H1083629, H1083630 SRB29ACLot Numbers: H1068591S1, H1078183, H1083631 SRB29MEDLot Numbers: H1068589S1, H1078184, H1078185, H1083633. - Amount recalled
- 1,940 units total
Where it was sold
- Nationwide
- VA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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