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Merit PreludeSync Radial Compression Device
- Starting date:
- March 6, 2017
- Posting date:
- April 13, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63006
Reason
Wrist band fiber particulate was identified on the sealing surface inside the valve, preventing a complete seal of the inflation valve resulting in a slow balloon air leak.
Affected products
Merit PreludeSync Radial Compression Device
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- SRB24AC
- SRB24MED
- SRB29AC
- SRB29MED
Companies
- Manufacturer
-
Merit Medical Systems Inc.
1600 West Merit Parkway
South Jordan
84095
Utah
UNITED STATES