CLASS III Device recall · Reported 6 Feb 2019 · FDA Enforcement Report
RP Riverpoint Medical Brachy Grid B&k(TM) style recalled
Riverpoint Medical is recalling RP Riverpoint Medical Brachy Grid B&k(TM) style, distributed nationwide in the US. The recall was initiated on 9 Jan 2018 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0777-2019
- FDA event ID
- 81935
- Recalling firm
- Riverpoint Medical, Portland, OR
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Jan 2018
- FDA classified
- 28 Jan 2019
- Reported
- 6 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 9 Jan 2018 | Recall initiated by company | |
| 28 Jan 2019 | Classified by FDA | +384 days |
| 6 Feb 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product is labeled with "CE", but is not yet approved in the European Union.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution in the states of IL, WA, and FL
Questions about this recall
Is RP Riverpoint Medical Brachy Grid B&k(TM) style recalled?
Yes. Riverpoint Medical recalled RP Riverpoint Medical Brachy Grid B&k(TM) style on 9 Jan 2018. The recall is Class III and its status is Terminated. Recall number Z-0777-2019.
Why was it recalled?
Product is labeled with "CE", but is not yet approved in the European Union.
Which lots are affected?
Lot Numbers: 18061816, 18101521
Where was it sold?
US Nationwide Distribution in the states of IL, WA, and FL
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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