Recall Z-2781-2020 ยท HDD Table, Obstetrical, Ac-Powered (And Accessories)
Linet Americas
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.
| Date | Mar 6, 2020 |
| Status | Open, Classified |
| Reason | The UDI on the device label indicates incorrect manufacturer. |
| Root cause | Labeling mix-ups |
| Action | AVE 2 Birthing bed manufactured between the May and November 2019 have an incorrect UDI |
| Quantity | 202 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.