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Linet Americas recalls AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also
Recalled August 19, 2020 · FDA recall Z-2781-2020 · Linet Americas
Hazard
The UDI on the device label indicates incorrect manufacturer. · FDA Class III
Units
202 devices
Sold at
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.
Description
The UDI on the device label indicates incorrect manufacturer.
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.
Manufacturer(s)
Linet Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →