Recall Z-0777-2019— Riverpoint Medical, LLC
Class III · Terminated
Class III FDA medical device recall by Riverpoint Medical, LLC, initiated 2018-01-09, terminated 2019-04-15. FDA's recall record names no specific 510(k) clearance for this event. 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: Product is labeled with "CE", but is not yet approved in the European Union..
- Recalling firm
- Riverpoint Medical, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-01-09
- Terminated
- 2019-04-15
- Firm location
- Portland, OR, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.