FDA Device recall Z-0777-2019
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachythera…
- FDA Device
- Class III
- terminated
- Published 2019-02-06
On 2019-02-06 the FDA classified a Class III recall of RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachythera… by Riverpoint Medical, citing product is labeled with "CE", but is not yet approved in the European Union.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0777-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-01-09 |
| Published | 2019-02-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Riverpoint Medical |
| Distribution | US |
Product
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 computerized grids to aid in placement.
Reason
Product is labeled with "CE", but is not yet approved in the European Union.
Identifiers
| code_info | Lot Numbers: 18061816, 18101521 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Riverpoint Medical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0777-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.