FDA recall Z-1030-2022

Acera Surgical Inc · Class II · device

Product

Restrata, Part Number RWM1-2X2

Reason for recall

Misprinted expiration date on the shelf-box

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2022-03-21
Report date
2022-05-11
Termination date
2024-08-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woodstock, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1030-2022