Recall Z-0777-2019
Riverpoint Medical, LLC · initiated January 9, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Lot Numbers: 18061816, 18101521
Reason for recall
Product is labeled with "CE", but is not yet approved in the European Union.
FDA-determined 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.
Details
- Recall number
- Z-0777-2019
- Initiated
- January 9, 2018
- Terminated
- April 15, 2019
- Product code
- IWJ – System, Applicator, Radionuclide, Manual
- Quantity
- 443 devices
- Distribution
- US Nationwide Distribution in the states of IL, WA, and FL
- Recalling firm
- Riverpoint Medical, LLC, Portland, OR