Class 2 Device Recall Arjo Portable Scale Adaptor

• Date Initiated by Firm: February 17, 2023
• Date Posted: May 24, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1629-2023
• Recall Event ID: 92175
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment
• Code Information: UDI/DI 05055982760713, Serial Numbers: 300501841, 300501842, 300515661
• FEI Number: 3002655016
• Recalling Firm/ Manufacturer: Arjohuntleigh Magog, Inc.; 2001 Tanguay St; Magog Canada
• For Additional Information Contact: Darren DeMerritt; 423-308-9587
• Manufacturer Reason for Recall: Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.
• FDA Determined Cause: Process control
• Action: Arjo issue an URGENT MEDICAL DEVICE RECALL notice to its consignees on 02/17/2023 via letter, UPS, 2nd Day Delivery. The notice explained the problem, the risk, and requested the consignee remove the units from use and destroy them. The firm will be replacing the units upon receipt of the completed response form. For questions or assistance in completing the Customer Response Form, please contact Arjo at 1 800-323-1245 or via email at ArjoCustomer.Response-US@arjo.com.
• Quantity in Commerce: 3
• Distribution: US: OH, NY
• 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.