Recall Z-2031-2025 ยท FSA Lift, Patient, Non-Ac-Powered
Baxter Healthcare Corporation
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift - Product Code 2040006; 6) Viking XS Mobile Lift - Product Code 2040007;
| Date | Jul 9, 2025 (initiated May 30, 2025) |
| Status | Open, Classified |
| Reason | The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop. |
| Root cause | Device Design |
| Action | Baxter issued an URGENT PRODUCT RECALL notice to is consignees on 05/30/2025 via USPS first class mail. The notice described the problem with the device, hazard, and requested the following: "Actions to be taken by customers 1. Please locate and stop using all Q-link 13 components on any of the products listed in the affected product table. 2. Contact Baxter Technical Support to discuss alternative options, if necessary, at 800-445-3720, option 2, between the hours of 8:00 am and 6:00 pm Eastern Time, Monday through Friday, or by email at HRC_Technical_Support@Baxter.com. 3. Please post t |
| Quantity | 9899 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.