The PreludeSYNC Radial Compression Device is a sterile — Class II medical device recall Z-1766-2017
Terminated recall by Merit Medical Systems, Inc., reported 2017-04-19, distributed nationwide. Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device b
| Recall number | Z-1766-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2017-03-03 |
| Classified | 2017-04-10 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,940 units |
| Reason classes | specification failure, packaging |
| Lot numbers | H1068587S1, H1068589S1, H1068590S1, H1068591S1, H1073974, H1078177, H1078179, H1078180, H1078181, H1078183, H1078184, H1078185, H1083628, H1083629, H1083630, H1083631, H1083633 |
| Model numbers | SRB24AC, SRB24MED, SRB29AC, SRB29MED |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1766-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.