FDA recall Z-0829-2022

Baxter Healthcare Corporation · Class II · device

Product

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

Reason for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2022-02-21
Report date
2022-04-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0829-2022