Device product
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Z-1965-2021
Product summary
- Event
- Event 87993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-1965-2021
Official wording
Reason: There is a potential that the pressure tubing may detach from the blood sampling system
Code information: Lot # 63598812
Distribution pattern: US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
Derived failure modes
-
Unknown
There is a potential that the pressure tubing may detach from the blood sampling system