FDA recall Z-0777-2019

Riverpoint Medical, LLC · Class III · device

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 for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-01-09
Report date
2019-02-06
Termination date
2019-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portland, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0777-2019