Linet AVE 2 Birthing Bed Recalled for Incorrect Manufacturer Labeling
Linet Americas is recalling 202 AVE 2 Birthing Beds because the Unique Device Identifier (UDI) on the label indicates the incorrect manufacturer.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the manufacturer name on the UDI.
Plain-English summary
Linet Americas is recalling 202 units of the AVE 2 Birthing Bed. The recall was initiated because the Unique Device Identifier (UDI) on the device label indicates the incorrect manufacturer. The affected devices are designated for use by mothers ready for spontaneous vaginal delivery and as an aid for finding positions providing relief in all delivery stages, including the postpartum period.
The recall covers specific model numbers and lot numbers, including Model 4BCPPB-3XCZ0002, Model 4BCPPB-CCZ0008, and Model 4BCPPB-BCZ0009. The devices were distributed nationwide in the United States, including in states such as Arkansas, California, Delaware, Florida, Georgia, Indiana, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and Puerto Rico.
This recall is classified as Class III by the FDA, indicating that the use of or exposure to the device is not likely to cause adverse health consequences. Consumers and healthcare facilities should verify the UDI on their devices against the provided lot numbers to determine if they are affected.
The recalled product
- 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
- Manufacturer
- Linet Americas
- Category
- Medical Device — Hospital Bed
- Hazard
- Affected units
- 202
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distribution
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