Riverpoint Medical Recalls 18G Brachy Grids for Incorrect CE Labeling
Riverpoint Medical is recalling 443 units of 18G Brachy Grids because they are labeled with a CE mark despite not being approved in the European Union.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and labeling error regarding CE approval status.
Plain-English summary
Riverpoint Medical, LLC is recalling 443 units of the 18G Brachy Grid B&K(TM) style (REF RPG-18). The recall is due to a labeling error where the product is marked with "CE" but has not yet received approval in the European Union.
The affected devices are used during brachytherapy procedures to assist with the precise insertion of needles or other probes. The recall covers lot numbers 18061816 and 18101521. The products were distributed nationwide in the United States, specifically in Illinois, Washington, and Florida.
No injuries or illnesses have been reported in connection with this recall. The FDA has classified this recall as Class III, indicating that the labeling error is unlikely to cause adverse health consequences. Users should stop using the affected devices and contact Riverpoint Medical for further instructions.
The recalled product
- 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…
- Manufacturer
- Riverpoint Medical, LLC
- Hazard
- Affected units
- 443
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: 18061816
- 18101521
Distribution
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