Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043

FDA device recall Z-1816-2025 · posted 2025-05-23 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

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.

Action taken

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 phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the Medical Director/Office Manager, Biomedical Engineering, OB/GYN Unit Director/Manager, Director of Pharmacy, Risk Manager, Purchasing Director/Head of Central Supply and any other departments within your institution who use the affected product. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal. Further Information and Support For general questions regarding this communication, please contact Baxter Technical Support at 800-445-3720 (press option 2, then option 1) between the hours of 8:00 am and 6:00 pm Central Time, Monday through Friday.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

KNC

Quantity affected

164 units

Distribution

Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.

Date initiated

2025-05-06

Date posted

2025-05-23

Location

Deerfield, IL