Recall Z-2781-2020— Linet Americas
Class III · Ongoing
Class III FDA medical device recall by Linet Americas, initiated 2020-03-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The UDI on the device label indicates incorrect manufacturer..
- Recalling firm
- Linet Americas
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2020-03-06
- Firm location
- Charlotte, NC, United States
Product 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 for recall
The UDI on the device label indicates incorrect manufacturer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.