Device product
ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
Z-2487-2019
Product summary
- Event
- Event 83523
- Status
- Terminated
- Classification
- Class II
- Quantity
- 722 kits
- Official record key
device-enforcement:Z-2487-2019
Official wording
Reason: Prolonged clotting times
Code information: Lot # : 42255701
Distribution pattern: States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.
Derived failure modes
-
Unknown
Prolonged clotting times