FDA Recall
Open, Classified
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.
Recall: Z-2781-2020
·
Initiated March 6, 2020
Recall
- Recall Number
- Z-2781-2020
- Event Number
- 85094
- Firm
- Linet Americas
- FEI Number
- 3008007426
- Product Code
- HDD
- Status
- Open, Classified
- Root Cause
- Labeling mix-ups
- Initiated
- March 6, 2020
- Address
- 10420 Harris Oak Blvd, Charlotte, NC, 28269-7517
Description
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
The UDI on the device label indicates incorrect manufacturer.
Action
AVE 2 Birthing bed manufactured between the May and November 2019 have an incorrect UDI
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.
Quantity
202 devices