Summary
The FDA issued a Class II for ActiveAid 922, Shower/Commode Chair by Altimate Medical, Inc.. Reason: 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 positio.
Details
Source
Device Recall
External ID
Z-0880-2023
Action Date
2023-01-11
Status
Terminated
Category
device
Product Description
ActiveAid 922, Shower/Commode Chair
Lot/Code Info: Serial Number 90071504001
Quantity Affected: 1 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.
Distribution
US Nationwide distribution in the state of Texas.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-30
Company
Morton, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Altimate Medical, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Altimate Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Altimate Medical, Inc. have FDA actions?
Altimate Medical, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0880-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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