PlainRecalls
FDA Devices Moderate Class II Ongoing

Allen Advance Chest Support with Pad

Reported: July 19, 2023 Initiated: May 18, 2023 #Z-2109-2023

Product Description

Allen Advance Chest Support with Pad

Reason for Recall

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

Details

Units Affected
1,010 units
Distribution
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.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Allen Advance Chest Support with Pad. Recalled by Baxter Healthcare Corporation. Units affected: 1,010 units.
Why was this product recalled?
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 19, 2023. Severity: Moderate. Recall number: Z-2109-2023.