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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Twinbar 670 QRH

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  Class 2 Device Recall Universal Twinbar 670 QRH see related information
Date Initiated by Firm February 21, 2022
Create Date March 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-0829-2022
Recall Event ID 89598
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
Code Information Manufactured before 28OCT2021, UDI 00887761982468
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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