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U.S. Department of Health and Human Services

Class 3 Device Recall RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style

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  Class 3 Device Recall RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style see related information
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
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
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
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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