PreludeSYNC Distal Radial Compression Device (2020-03-13)
- Starting date:
- March 13, 2020
- Posting date:
- April 17, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72777
Last updated: 2020-04-17
Affected Products
PreludeSYNC Distal Radial Compression Device
Reason
During the sterilization process, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression.
Affected products
PreludeSYNC Distal Radial Compression Device
Lot or serial number
- H1559517
- H1666548
Model or catalog number
- SDRB-REG-LT
- SDRB-REG-RT
Companies
- Manufacturer
-
Merit Medical Systems Inc.
1600 West Merit Parkway
South Jordan
84095
Alabama
UNITED STATES