Recall Z-1766-2017
Merit Medical Systems, Inc. · initiated March 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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.
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: Process control
Action taken
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.
Details
- Recall number
- Z-1766-2017
- Initiated
- March 3, 2017
- Posted by FDA
- April 10, 2017
- Terminated
- June 21, 2017
- Product code
- DXC – Clamp, Vascular
- Quantity
- 1,940 units total
- Distribution
- Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT