Z-0795-2020 Class II Terminated
FDA device recall Z-0795-2020 was initiated by Riverpoint Medical, LLC on February 8, 2019 and is designated Class II. Reason for recall: The integrity of the sterile grid packaging is potentially compromised. The recall status is terminated (terminated April 28, 2021). Affected quantity: 3,234 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- February 8, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,234 devices
Product Description
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 Pattern
Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution.
Code Information
Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.