Class 2 Device Recall Chest support for R82 Mustang and Rabbit

• Date Initiated by Firm: March 06, 2020
• Create Date: May 04, 2020
• Recall Status: Terminated on September 05, 2023
• Recall Number: Z-1858-2020
• Recall Event ID: 85210
• Product Classification: Walker, mechanical - Product Code ITJ
• Product: Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
• Code Information: All units distributed from 04/01/2017 to 02/10/2020
• Recalling Firm/ Manufacturer: R82 A/S; Parallelvej 3; Gedved Denmark
• Manufacturer Reason for Recall: The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
• FDA Determined Cause: Device Design
• Action: R82, Inc. notified their sole consignee on 02/09/2020 by email. The notice identified the choking hazard and requested that the consignee notify their customers of the hazard. The consignee will be sending letters beginning the week of 03/16/2020 to their customers.
• Quantity in Commerce: 2230 units
• Distribution: NC
• 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.