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.
This recall has been terminated (originally issued January 10, 2020).
- Company
- Riverpoint Medical, Llc
- Recall Initiated
- February 8, 2019
- Posted
- January 10, 2020
- Terminated
- April 28, 2021
- Recall Number
- Z-0795-2020
- Quantity
- 3,234 devices
- Firm Location
- Portland, OR
- Official Source
- View on FDA website ↗
Reason for Recall
The integrity of the sterile grid packaging is potentially compromised.
Distribution
Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution.
Lot / Code Info
Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.
Root Cause
Packaging
Action Taken
Recall notifications dated 2/8/2019 were issued via email and overnight mail on 2/8/2019.
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