# FDA recall Z-1289-2024

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2024-02-14.

## Product

STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

## Reason for recall

Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.

## Distribution

US Nationwide distribution in the state of Alabama.

## Key facts

- **Recall number:** Z-1289-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-14
- **Report date:** 2024-03-20

- **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-1289-2024

## Citation

> AI Analytics. FDA recall Z-1289-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1289-2024. Source: US FDA. Licensed CC0.

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