AVE 2 Birthing Bed - Product Usage: is designated to be recall
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…
Why was AVE 2 Birthing Bed - Product Usage: is designated to be recalled?
The UDI on the device label indicates incorrect manufacturer.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Linet Americas
- 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.
- Recall date
- August 19, 2020
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)