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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0880-2023 | Class II | Terminated | Voluntary: Firm initiated |
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