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.
This recall has been terminated (originally issued January 9, 2018).
- Company
- Riverpoint Medical, Llc
- Recall Initiated
- January 9, 2018
- Terminated
- April 15, 2019
- Recall Number
- Z-0777-2019
- Quantity
- 443 devices
- Firm Location
- Portland, OR
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot Numbers: 18061816, 18101521
Root Cause
Error in labeling
Action Taken
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.
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