Z-0777-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 6, 2019
- Initiation Date
- January 9, 2018
- Termination Date
- April 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 443 devices
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.
Distribution Pattern
US Nationwide Distribution in the states of IL, WA, and FL
Code Information
Lot Numbers: 18061816, 18101521