# FDA recall Z-2109-2023

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2023-05-18.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-2109-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-18
- **Report date:** 2023-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2023

## Citation

> AI Analytics. FDA recall Z-2109-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2109-2023. Source: US FDA. Licensed CC0.

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