FDA recall Z-0795-2020

Riverpoint Medical, LLC · Class II · 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.

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.

Key facts

Status
Terminated
Initiation date
2019-02-08
Report date
2020-01-22
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portland, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0795-2020