FDAClass IIMarch 30, 2022

Compella Bariatric Bed System recall

Compella Bariatric Bed System

Why was Compella Bariatric Bed System recalled?

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots/serial numbers UDI information: Compella Bariatric Bed - 00887761000902

Product
Compella Bariatric Bed System
Recalling firm
Baxter Healthcare Corporation
Quantity
5186 units
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.
Recall date
March 30, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls