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.

Company

Linet Americas

Recall Initiated

March 6, 2020

Recall Number

Z-2781-2020

Quantity

202 devices

Firm Location

Charlotte, NC

Reason for Recall

The UDI on the device label indicates incorrect manufacturer.

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.

Lot / Code Info

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

Root Cause

Labeling mix-ups

Action Taken

AVE 2 Birthing bed manufactured between the May and November 2019 have an incorrect UDI