The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maint
FDA device recall Z-1766-2017 · posted 2017-04-10 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DXC
- Quantity affected
- 1,940 units total
- Distribution
- Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.
- Date initiated
- 2017-03-03
- Date posted
- 2017-04-10
- Date terminated
- 2017-06-21
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PreludeSYNC Radial Compression Device (K162988) | Merit Medical Systems, Inc. | 2017-01-25 |