Device product
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Z-1962-2021
Product summary
- Event
- Event 87993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,000 units
- Official record key
device-enforcement:Z-1962-2021
Official wording
Reason: There is a potential that the pressure tubing may detach from the blood sampling system
Code information: Lot # 63456332
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