Z-1766-2017Class II

The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in...

Name: Z-1766-2017 The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in...
Creator: Merit Medical Systems, Inc.
Published: 2017-03-03
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2017-03-03 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and... on 2017-03-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1766-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Posted: 2017-04-10
Terminated: 2017-06-21
Recalling firm: Merit Medical Systems, Inc.
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.
Product code: DXC Clamp, Vascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 1,940 units total
Distribution: Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1766-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1766-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-10

Product code DXC

K162988Class IIPreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. / cleared 2017-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)