Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0880-2023Class II

ActiveAid 922, Shower/Commode Chair

Altimate Medical, Inc. / initiated 2022-11-30 / Terminated / root cause: manufacturing process

Altimate Medical, Inc. began a recall of ActiveAid 922, Shower/Commode Chair on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0880-2023
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Altimate Medical, Inc.
Product
ActiveAid 922, Shower/Commode Chair
Product code
INN Chair, Adjustable, Mechanical
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.
Root cause tag
manufacturing process
FDA root 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.
Product codes and lots
Serial Number 90071504001

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0880-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0880-2023Class IITerminatedVoluntary: Firm initiated