Device product
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Z-2051-2021
Product summary
- Event
- Event 88074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,752 units
- Official record key
device-enforcement:Z-2051-2021
Official wording
Reason: There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
Code information: Product Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.
Distribution pattern: United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.
Derived failure modes
-
Unknown
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date