Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2032-2025Class I

Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1)...

Baxter Healthcare Corporation / initiated 2025-05-30 / Open, Classified / root cause: design

Baxter Healthcare Corporation began a recall of Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225... on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-2032-2025
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Baxter Healthcare Corporation
Product
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
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 tag
design
FDA 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 [email protected]. 3. Please post this letter in areas where affected mobile lifts are stored and used. 4. 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. 5. 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. 6. Please forward a copy of this communication to all departments within your institution that use the affected mobile lifts. 7. If you are a dealer, wholesaler or distributor/reseller that distributed any affected product to other facilities, please forward this communication to your customers 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 Option 2 between the hours of 8:00 am and 6:00 pm Eastern Time, Monday through Friday, or by email at HRC_Technical_Sup
Quantity in commerce
9839 units
Distribution
Worldwide
Product codes and lots
All LikoScale Adapter Kits manufactured between 8/27/2013 to 2/27/2025

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2032-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2031-2025Class IOngoingVoluntary: Firm initiated
Z-2032-2025Class IOngoingVoluntary: Firm initiated