PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: February 6, 2019 Initiated: January 9, 2018 #Z-0777-2019

Product Description

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.

Details

Recalling Firm
Riverpoint Medical, LLC
Units Affected
443 devices
Distribution
US Nationwide Distribution in the states of IL, WA, and FL
Location
Portland, OR

Frequently Asked Questions

What product 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.. Recalled by Riverpoint Medical, LLC. Units affected: 443 devices.
Why was this product recalled?
Product is labeled with "CE", but is not yet approved in the European Union.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 6, 2019. Severity: Low. Recall number: Z-0777-2019.