Class 2 Device Recall Altimate Medical

• Date Initiated by Firm: November 30, 2022
• Date Posted: January 04, 2023
• Recall Status: Terminated on August 31, 2023
• Recall Number: Z-0880-2023
• Recall Event ID: 91335
• Product Classification: Chair, adjustable, mechanical - Product Code INN
• Product: ActiveAid 922, Shower/Commode Chair
• Code Information: Serial Number 90071504001
• Recalling Firm/ Manufacturer: Altimate Medical, Inc.; 262 W 1st St; Morton MN 56270-1179
• For Additional Information Contact: Amy Curtis; 507-697-6393
• Manufacturer Reason for Recall: Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.
• FDA Determined Cause: Component change control
• Action: Altimate Medical notified its sole consignee by telephone on 11/30/2022 and followed with an Urgent Medical Device Recall letter on 12/06/2022. The notice stated the problem and requested the following action: "- Acknowledge receipt of this notification. Complete and return the attached Acknowledgement form. - Inform the customer not to use the chair if this has not already done. - Provide replacement chair 90071504001 under RMA000737 to AMI - Inform Altimate when the replacement chair is provided to the customer. Complete and return the attached Verification form."
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide distribution in the state of Texas.
• 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.