Recall Z-0829-2022 ยท FSA Lift, Patient, Non-Ac-Powered
Baxter Healthcare Corporation
Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
| Date | Feb 21, 2022 |
| Status | Open, Classified |
| Reason | An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use. |
| 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 cons |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.