Merit Medical Recalls PreludeSYNC Radial Compression Devices Due to Valve Seal Defect
Merit Medical Systems is recalling 1,940 PreludeSYNC Radial Compression Devices because manufacturing particulates may prevent the inflation valve from sealing completely.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary field action for a manufacturing defect that may prevent a complete seal, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Merit Medical Systems, Inc. is conducting a voluntary field action for the PreludeSYNC Radial Compression Device. This sterile, single-use disposable device is used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. The device features a soft wristband, an inflatable bulb, and a check valve for inflation and deflation.
The recall is being issued because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve. A total of 1,940 units are affected. The devices were distributed nationwide, to Canadian consignees, and to other foreign consignees. No VA, government, or military consignees are affected.
The affected products include specific catalog numbers and lot numbers: SRB24AC (Lots H1068590S1, H1078177, H1078180, H1083628); SRB24MED (Lots H1068587S1, H1073974, H1078179, H1078181, H1083629, H1083630); SRB29AC (Lots H1068591S1, H1078183, H1083631); and SRB29MED (Lots H1068589S1, H1078184, H1078185, H1083633). Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- 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…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 1,940
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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