Device product
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Z-2550-2018
Product summary
- Event
- Event 80283
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 cases/2 units (Total 60 units)
- Official record key
device-enforcement:Z-2550-2018
Official wording
Reason: Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Code information: Lot Number: VE17
Distribution pattern: US state of FL
Derived failure modes
-
Unknown
Kit was labeled with the incorrect Expiration Date of April 30, 2019.