FDA recall Z-2781-2020

Linet Americas · Class III · device

Product

AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.

Reason for recall

The UDI on the device label indicates incorrect manufacturer.

Distribution

US Nationwide distribution including in the states of Arkansas, California, Delaware, Florida, Georgia, Indiana, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia and Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2020-03-06
Report date
2020-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Charlotte, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2781-2020