Recall Z-0795-2020 ยท IWJ System, Applicator, Radionuclide, Manual
Riverpoint Medical, LLC
Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.
| Date | Jan 10, 2020 (initiated Feb 8, 2019) |
| Status | Terminated |
| Reason | The integrity of the sterile grid packaging is potentially compromised. |
| Root cause | Packaging |
| Action | Recall notifications dated 2/8/2019 were issued via email and overnight mail on 2/8/2019. |
| Quantity | 3,234 devices |
| Distribution | Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.