Reported Feb 6, 2019 · Terminated
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is…
Riverpoint Medical, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Riverpoint Medical, LLC · 825 NE 25th Ave · Portland, OR · 97232-2304
Is this the product you have?
- RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style
- REF RPG-18 Product UsageThe 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
- Lot codes and dates
- Lot Numbers
1806181618101521
- Lot Numbers
- Amount recalled
- 443 devices
Where it was sold
Why it was recalled
Product is labeled with "CE", but is not yet approved in the European Union.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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