Z-0829-2022Class II

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

Name: Z-0829-2022 Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers...
Creator: Baxter Healthcare Corporation
Published: 2022-02-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-02-21 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087 on 2022-02-21. FDA classified it as Class II and gives the reason as "An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0829-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-21
Posted: 2022-03-28
Recalling firm: Baxter Healthcare Corporation
Product: Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 1,399 twinbars
Distribution: 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.
Product codes and lots: Manufactured before 28OCT2021, UDI 00887761982468

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0829-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0829-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-28

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)