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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Baxter Healthcare Corporation: Boot Assembly Recalled for Detachment Risk and Potential Surgical Delay

Agency Publication Date: March 12, 2024
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Summary

Baxter Healthcare Corporation is recalling 14 units of the STERIS Boot Assembly, Traction Device (Model OT 1000) because of an incorrectly oriented locking pin. This defect can cause the boot to detach from the traction system during medical procedures. There has been at least one customer report of this detachment occurring, which can lead to patient harm and significant delays during surgery. Consumers should identify if they have the affected part number REF 10009192 and contact the manufacturer immediately.

Risk

If the locking pin is oriented incorrectly, the boot may suddenly detach from the traction system during a surgical procedure, potentially causing physical injury to the patient or interrupting critical surgical workflows.

What You Should Do

  1. Locate the traction device boot assembly and check the part number and lot information on the device or its packaging.
  2. Identify if your device is a STERIS Boot Assembly, Traction Device, OT 1000 with Part Number REF 10009192.
  3. Verify if your unit belongs to one of the following affected lot numbers: 23-140, 23-268, or 23-314.
  4. Check the UDI/DI barcode number 00615521000851 to confirm if your product is included in this recall.
  5. If you have an affected device, stop using it immediately and contact Baxter Healthcare Corporation or your healthcare facility's equipment manager.
  6. Contact Baxter Healthcare Corporation at their Deerfield, Illinois headquarters or through their official customer support channels for instructions on returning or servicing the device.
  7. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer contact and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Model / REF:
REF 10009192
OT 1000
UPC Codes:
00615521000851
Lot Numbers:
23-140
23-268
23-314

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94037
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Baxter Healthcare Corporation
Manufactured In: United States
Units Affected: 14 units
Distributed To: Alabama

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.