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Riverpoint Medical, LLC recalls RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is
Recalled February 6, 2019 · FDA recall Z-0777-2019 · Riverpoint Medical
Hazard
Product is labeled with "CE", but is not yet approved in the European Union. · FDA Class III
Units
443 devices
Sold at
US Nationwide Distribution in the states of IL, WA, and FL
Description
Product is labeled with "CE", but is not yet approved in the European Union.
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.
Manufacturer(s)
Riverpoint Medical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →