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U.S. Department of Health and Human Services

Class 2 Device Recall Altimate Medical

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  Class 2 Device Recall Altimate Medical see related information
Date Initiated by Firm November 30, 2022
Date Posted January 04, 2023
Recall Status1 Terminated 3 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 2		 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.
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