Device product
BASIN SET, MEBS42K, general surgical kit
Z-0274-2023
Product summary
- Event
- Event 91077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1504 trays
- Official record key
device-enforcement:Z-0274-2023
Official wording
Reason: Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
Code information: UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
labeling error