Class 2 Device Recall Multirall(TM) 200

• Date Initiated by Firm: July 17, 2018
• Create Date: October 12, 2018
• Recall Status: Terminated on April 19, 2019
• Recall Number: Z-0105-2019
• Recall Event ID: 80911
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations.
• Code Information: Part Number 3136250, the manufacturing date is on the right side of the label listed as 2017-05-05.
• FEI Number: 6884
• Recalling Firm/ Manufacturer: Liko AB; Alvik 7555; Lulea Sweden
• Manufacturer Reason for Recall: The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled products is used for patient transport, this could allow the patient to fall, resulting in potential injury to the patient.
• FDA Determined Cause: Storage
• Action: The customer was contacted via telephone on 7/17/18 to notify them of the recall. An Urgent Field Safety Notice notification letter was sent to the customer on 7/19/18.
• Quantity in Commerce: 2
• Distribution: The products were distributed to the following US states: OH.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.