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U.S. Department of Health and Human Services

Class 2 Device Recall PreludeSYNC Radial Compression Device

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 Class 2 Device Recall PreludeSYNC Radial Compression Devicesee related information
Date Initiated by FirmMarch 03, 2017
Date PostedApril 10, 2017
Recall Status1 Terminated 3 on June 21, 2017
Recall NumberZ-1766-2017
Recall Event ID 76762
510(K)NumberK162988 
Product Classification Clamp, vascular - Product Code DXC
ProductThe 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information ContactZach Borla
801-253-1600
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionMerit 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 Commerce1,940 units total
DistributionNationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXC
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