ActiveAid 922, Shower/Commode Chair
FDA device recall Z-0880-2023 · posted 2023-01-04 · Terminated
Recall details
- Recalling firm
- Altimate Medical, Inc.
- 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.
- 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."
- Root cause
- Component change control
- Status
- Terminated
- Product code
- INN
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of Texas.
- Date initiated
- 2022-11-30
- Date posted
- 2023-01-04
- Date terminated
- 2023-08-31
- Location
- Morton, MN
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