Recall record at a glance
| Official record | Z-0829-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Baxter Healthcare Corporation |
| Report date | Apr 6, 2022 |
| Recall initiation date | Feb 21, 2022 |
| Quantity | 1,399 twinbars |
| Location | Deerfield, IL, United States |
Official product description
Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
Why the product was recalled
An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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