Device product
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
Z-2741-2016
Product summary
- Event
- Event 74986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 690 kits
- Official record key
device-enforcement:Z-2741-2016
Official wording
Reason: Shipping carton labeling error.
Code information: Device Listing # D025180
Distribution pattern: Nationwide Distribution to OH, IN, TN, NC, and KY.
Derived failure modes
-
Labeling or packaging
labeling error