Recall Z-1816-2025 ยท KNC Table, Obstetric (And Accessories)
Baxter Healthcare Corporation
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455, P3700E100456, P3700E100457, P3700E100459, P3700E100463, P3700E100468, P3700E10047
| Date | May 23, 2025 (initiated May 6, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 5/6/25 was sent to customers. Actions to be Taken by Customers 1. Customers may continue to use the potentially impacted beds until an inspection/correction has been performed by Baxter. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phon |
| Quantity | 164 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.