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U.S. Department of Health and Human Services

Class 3 Device Recall AVE 2 Birthing Bed

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  Class 3 Device Recall AVE 2 Birthing Bed see related information
Date Initiated by Firm March 06, 2020
Create Date August 12, 2020
Recall Status1 Open3, Classified
Recall Number Z-2781-2020
Recall Event ID 85094
Product Classification Table, obstetrical, ac-powered (and accessories) - Product Code HDD
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.
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
Recalling Firm/
Manufacturer		 Linet Americas
10420 Harris Oak Blvd
Charlotte NC 28269-7517
For Additional Information Contact Bryan Ashe
877-815-9897
Manufacturer Reason
for Recall		 The UDI on the device label indicates incorrect manufacturer.
FDA Determined
Cause 2		 Labeling mix-ups
Action AVE 2 Birthing bed manufactured between the May and November 2019 have an incorrect UDI
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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