Z-2781-2020 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- March 6, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 202 devices
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.
Distribution Pattern
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.
Code Information
Model Number 4BCPPB-3XCZ0002 (Lot Numbers PPB1155 - PPB1174, PPB1194 - PPB1213, PPB1222 - PPB1241, PPB1265 - PPB1284, PPB1292 - PPB1311, PPB1346 - PPB1365, PPB1375 - PPB1394, PPB1451 - PPB1466, PPB1477 - PPB1496, PPB1508 - PPB1527); Model Number 4BCPPB-CCZ0008, Lot Number PPB1446 - PPB1449; Model Number 4BCPPB-BCZ0009, Lot Number PPB1541 - PPB1542