Date Initiated by Firm | January 09, 2018 |
Create Date | January 28, 2019 |
Recall Status1 |
Terminated 3 on April 15, 2019 |
Recall Number | Z-0777-2019 |
Recall Event ID |
81935 |
Product Classification |
System, applicator, radionuclide, manual - Product Code IWJ
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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. |
Code Information |
Lot Numbers: 18061816, 18101521 |
Recalling Firm/ Manufacturer |
Riverpoint Medical, LLC 825 NE 25th Ave Portland OR 97232-2304
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For Additional Information Contact | Mr. Pat Ferguson 503-517-8001 |
Manufacturer Reason for Recall | Product is labeled with "CE", but is not yet approved in the European Union. |
FDA Determined Cause 2 | Error in labeling |
Action | 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. |
Quantity in Commerce | 443 devices |
Distribution | US Nationwide Distribution in the states of IL, WA, and FL |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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