Recall Z-0777-2019 ยท IWJ System, Applicator, Radionuclide, Manual
Riverpoint Medical, LLC
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with
| Date | Jan 9, 2018 |
| Status | Terminated |
| Reason | Product is labeled with "CE", but is not yet approved in the European Union. |
| Root cause | Error in labeling |
| Action | The firm initiated the recall by telephone following with an email and letter on 01/09/02019 The firm requested the return of the recalled product. |
| Quantity | 443 devices |
| Distribution | US Nationwide Distribution in the states of IL, WA, and FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.