Device product
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
Z-1959-2021
Product summary
- Event
- Event 87993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 460 units
- Official record key
device-enforcement:Z-1959-2021
Official wording
Reason: There is a potential that the pressure tubing may detach from the blood sampling system
Code information: Lot #s: 63505216 and 63590087
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