The PreludeSYNC Radial Compression Device is a sterile recall: Particulate Matter
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the…
Why was The PreludeSYNC Radial Compression Device is a sterile 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1,940 units total
- Distribution
- Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
- Recall date
- April 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)