Device 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.
Z-0795-2020
Product summary
- Event
- Event 84528
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,234 devices
- Official record key
device-enforcement:Z-0795-2020
Official wording
Reason: The integrity of the sterile grid packaging is potentially compromised.
Code information: Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.
Distribution pattern: Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution.
Derived failure modes
-
Sterility assurance
sterile grid packaging is potentially compromised