Recall Z-0795-2020
Riverpoint Medical, LLC · initiated February 8, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.
Reason for recall
The integrity of the sterile grid packaging is potentially compromised.
FDA-determined cause: Packaging
Action taken
Recall notifications dated 2/8/2019 were issued via email and overnight mail on 2/8/2019.
Details
- Recall number
- Z-0795-2020
- Initiated
- February 8, 2019
- Posted by FDA
- January 10, 2020
- Terminated
- April 28, 2021
- Product code
- IWJ – System, Applicator, Radionuclide, Manual
- Quantity
- 3,234 devices
- Distribution
- Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution.
- Recalling firm
- Riverpoint Medical, LLC, Portland, OR