Device product
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
Z-2201-2016
Product summary
- Event
- Event 74489
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units in total
- Official record key
device-enforcement:Z-2201-2016
Official wording
Reason: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
Code information: Lot/Batch Numbers: 23F14M0829, 23F14M0986
Distribution pattern: US distribution in the states of TN and KY.
Derived failure modes
-
Labeling or packaging
Labeling error