FDA-Device2020-08-19Class III
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.
Linet Americas
Hazard
The UDI on the device label indicates incorrect manufacturer.
Sold states
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.
Affected count
202 devices
Manufactured in
10420 Harris Oak Blvd, N/A, Charlotte, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2781-2020Don't want to check this manually?
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