Linet Americas recalls AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also…

Recall date

March 6, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2781-2020

FDA classification

Class III

Brand / firm

Linet Americas

Sold / distributed

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.

Why it was recalled

The UDI on the device label indicates incorrect manufacturer.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.