Device product
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
Z-0411-2020
Product summary
- Event
- Event 84072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30
- Official record key
device-enforcement:Z-0411-2020
Official wording
Reason: The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
Code information: Lot 5476032
Distribution pattern: The products were distributed to the following US states: LA, MA, OR, VA, and WA.
Derived failure modes
-
Unknown
The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.