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Recall Observatory FDA recall evidence

Device product

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

Z-0829-2022

February 21, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 89598
Status
Ongoing
Classification
Class II
Quantity
1,399 twinbars
Official record key
device-enforcement:Z-0829-2022

Official wording

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

Code information: Manufactured before 28OCT2021, UDI 00887761982468

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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