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Terminated

ActiveAid 922, Shower/Commode Chair

FDA Recall Z-0880-2023 · Posted 2023-01-04

Recalling FirmAltimate Medical, Inc.
Recall StatusTerminated
Product CodeINN
Date Initiated2022-11-30
Date Terminated2023-08-31
Product Quantity1 unit

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.

Firm 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."

Root Cause

Component change control

Distribution Pattern

US Nationwide distribution in the state of Texas.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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