Riverpoint Medical, LLC recalls RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is use…

Recall date

January 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0777-2019

FDA classification

Class III

Brand / firm

Riverpoint Medical, LLC

Sold / distributed

US Nationwide Distribution in the states of IL, WA, and FL

Why it was recalled

Product is labeled with "CE", but is not yet approved in the European Union.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.