Z-1766-2017 Class II Terminated
FDA device recall Z-1766-2017 was initiated by Merit Medical Systems, Inc. on March 3, 2017 and is designated Class II. 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, prevent… The recall status is terminated (terminated June 21, 2017). Affected quantity: 1,940 units total.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 3, 2017
- Termination Date
- June 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,940 units total
Product Description
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.
Distribution Pattern
Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
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.