Reported May 6, 2020 · Terminated
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
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?
- PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
- Lot codes and dates
- SDRB-REG-LTLot(UDI): H1559517(10884450363673) and H1727668(00884450363676)
- SDRB-REG-RTLot(UDI): H1666548(10884450363659) and H1723973(10884450363659)
- Amount recalled
- 1932
Where it was sold
Why it was recalled
During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.
This product could cause temporary or reversible health problems — stop using it.
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