ActiveAid 922, Shower/Commode Chair
This recall has been terminated (originally issued January 4, 2023).
- Company
- Altimate Medical, Inc.
- Recall Initiated
- November 30, 2022
- Posted
- January 4, 2023
- Terminated
- August 31, 2023
- Recall Number
- Z-0880-2023
- Quantity
- 1 unit
- Firm Location
- Morton, MN
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the state of Texas.
Lot / Code Info
Serial Number 90071504001
Root Cause
Component change control
Action Taken
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."