Summary
The FDA issued a Class II for Compella Bariatric Bed System by Baxter Healthcare Corporation. Reason: Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains..
Details
Source
Device Recall
External ID
Z-0820-2022
Action Date
2022-03-30
Status
Completed
Category
device
Product Description
Compella Bariatric Bed System
Lot/Code Info: All lots/serial numbers UDI information: Compella Bariatric Bed - 00887761000902
Quantity Affected: 5186 units
Reason for Recall
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkmenistan, UAE, and UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-14
Company
Deerfield, IL
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 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
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 (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0820-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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