—#154106

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.

FDA product code: DXC — Clamp, Vascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K162988
Affected lot / code info: Catalog Number: SRB24AC, Lot Numbers: H1068590S1, H1078177, H1078180, H1083628; Catalog Number: SRB24MED, Lot Numbers: H1068587S1,H1073974, H1078179, H1078181, H1083629, H1083630; Catalog Number: SRB29AC, Lot Numbers: H1068591S1, H1078183, H1083631; Catalog Number: SRB29MED, Lot Numbers: H1068589S1, H1078184, H1078185, H1083633.

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.

Root cause (FDA determination)

Process control

Action the firm took

Merit Medical sent an Urgent Product Recall Notice on March 3, 2017, via letter for consignees to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact Merit Customer Service at (801) 208-4381. For further questions regarding this recall, please call (801) 253-1600.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.

Timeline

Recall initiated: 2017-03-03
Posted by FDA: 2017-04-10
Terminated: 2017-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154106. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.