CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

The PreludeSYNC Radial Compression Device is a sterile recalled

Merit Medical Systems is recalling The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used, distributed nationwide in the US. The recall was initiated on 3 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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.

Quantity recalled1,940 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1766-2017
FDA event ID: 76762
Recalling firm: Merit Medical Systems, South Jordan, UT
Classification: Class II
Status: Terminated
Recall initiated: 3 Mar 2017
FDA classified: 10 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Heart & Vascular Devices

Timeline

3 Mar 2017	Recall initiated by company
10 Apr 2017	Classified by FDA	+38 days
19 Apr 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Virginia

Questions about this recall

Is The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used recalled?

Yes. Merit Medical Systems recalled The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used on 3 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1766-2017.

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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