—#192033

Product

Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.

FDA product code: FSA — Lift, Patient, Non-Ac-Powered
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Manufactured before 28OCT2021, UDI 00887761982468

Why it was recalled

An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The recalling firm issued letters to U.S. consignees on 2/21/2022 via UPS ground. The letter provided a description of the problem with the background which included photographs and views of the issue. The potential risk was explained and actions to be taken by the customer were provided, which included to identify whether they have an impacted product and to return the enclosed response form within two weeks. Upon receipt of the response form, Hillrom will contact the consignee to arrange to inspect the Twinbar and if the short bolts have been used, the Twinbar will be corrected. The consignee was instructed not to use the Twinbar together with a Liko Scale until an inspection has been completed. Distributors were instructed to share the Medical Device Correction with their end users and complete the attached response form for return within two weeks. Hillrom will provide replacements for distributors to facilitate exchange among end users. A 3rd party recall service will be issuing notifications to the OUS consignees.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, ND, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. There was government distribution but no military distribution. The countries of Austria, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Ireland, Japan, Jordan, Latvia, Netherlands, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Kingdom, and Uruguay.

Timeline

Recall initiated: 2022-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192033. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.