Device product
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Z-1465-2014
Product summary
- Event
- Event 67925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37 units
- Official record key
device-enforcement:Z-1465-2014
Official wording
Reason: Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits
Code information: Lot Number: RA-27
Distribution pattern: CA
Derived failure modes
-
Unknown
Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits