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U.S. Department of Health and Human Services

Class 2 Device Recall Riverpoint Medical 18G Brachy Grid

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  Class 2 Device Recall Riverpoint Medical 18G Brachy Grid see related information
Date Initiated by Firm February 08, 2019
Date Posted January 10, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-0795-2020
Recall Event ID 84528
Product Classification System, applicator, radionuclide, manual - Product Code IWJ
Product Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.
Code Information Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.
Recalling Firm/
Manufacturer		 Riverpoint Medical, LLC
825 NE 25th Ave
Portland OR 97232-2304
For Additional Information Contact Mr. Patrick J. Ferguson
503-517-8001
Manufacturer Reason
for Recall		 The integrity of the sterile grid packaging is potentially compromised.
FDA Determined
Cause 2		 Packaging
Action Recall notifications dated 2/8/2019 were issued via email and overnight mail on 2/8/2019.
Quantity in Commerce 3,234 devices
Distribution Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution.
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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