Device product
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
Z-1961-2021
Product summary
- Event
- Event 87993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 290 units
- Official record key
device-enforcement:Z-1961-2021
Official wording
Reason: There is a potential that the pressure tubing may detach from the blood sampling system
Code information: Lot # 63479666- Not Marketed within the US
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