FDA recall Z-2685-2024

ROi CPS LLC · Class II · device

Product

Regard Kit containing the Microtek decanter

Reason for recall

Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

Distribution

US Nationwide distribution in the state of MO.

Key facts

Status: Ongoing
Initiation date: 2024-06-17
Report date: 2024-08-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2685-2024