FDA-Device2023-07-19Class II
Allen Advance Chest Support with Pad
Baxter Healthcare Corporation
Hazard
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, Denmark, Egypt, France, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Affected count
1,010 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Allen Advance Chest Support with Pad
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2023Don't want to check this manually?
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