FDA Recall
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.
Recall: Z-0777-2019
·
Initiated January 9, 2018
Recall
- Recall Number
- Z-0777-2019
- Event Number
- 81935
- Firm
- Riverpoint Medical, LLC
- FEI Number
- 3006981798
- Product Code
- IWJ
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- January 9, 2018
- Terminated
- April 15, 2019
- Address
- 825 NE 25th Ave, Portland, OR, 97232-2304
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
Product is labeled with "CE", but is not yet approved in the European Union.
Action
The firm initiated the recall by telephone following with an email and letter on 01/09/02019 The firm requested the return of the recalled product.
Distribution
US Nationwide Distribution in the states of IL, WA, and FL
Quantity
443 devices