Recall Z-0411-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Angiodynamics Inc. (Navilyst Medical Inc.)
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
| Date | Oct 2, 2019 |
| Status | Terminated |
| Reason | The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay. |
| Root cause | Under Investigation by firm |
| Action | On October 2, 2019, AngioDynamics initiated a recall action by contacting customers by telephone and directing them to stop using the affected product and segregate until receipt of written the written recall notification. URgent Voluntary Medical Device Recall notification letters were sent to these customers on October 8, 2019. 1. Actions to be taken: " IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure locati |
| Quantity | 30 |
| Distribution | The products were distributed to the following US states: LA, MA, OR, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010060 | RITA STARBURST XLI ELECTROSURGICAL DEVICE Rita Medical Systems, Jan 23, 2001 |