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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Baxter Healthcare Corporation: HDS Traction Boot II Recalled Due to Assembly Error and Detachment Risk

Agency Publication Date: March 20, 2024
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Summary

Baxter Healthcare Corporation is recalling 80 units of the HDS Traction Boot II, model REF AR-6529-23, which is used during hip surgeries to support and position a patient's foot. The boots were assembled incorrectly with a locking ridge facing the wrong direction, which prevents the boot from properly attaching to the surgical traction system. This defect can cause the boot to unexpectedly detach from the system during a medical procedure. Consumers should contact their healthcare provider or the manufacturer regarding the affected units.

Risk

If the traction boot detaches during surgery, it can lead to a loss of necessary tension or positioning of the patient's limb, potentially resulting in surgical delays or injury to the patient. No specific injuries have been reported in the current data.

What You Should Do

  1. Identify if you have the HDS Traction Boot II by checking for model number REF AR-6529-23 and Recall number Z-1329-2024.
  2. Check the device for the following specific serial or identification numbers: 123510000293, 123510000294, 123510000295, 123510000296, 123510000298, 123510000299, 123510000300, 123510000764, 123510000765, 123510000766, 123510000767, 123510000768, 123510000769, 123510000770, 123510000771, 123510000772, 123510000773, 123510000800, 123510000801, 123510000802, 123510000803, 123510000804, 123510000805, 123510000806, 123510000807, 123510000808, 123510000809, 123510000297, 123350001033, 123350001034, 123350001035, 123350001036, 123350001040, 123350001041, 123350001042, 123360000294, 123360000295, 123360000297, 123360000298, 123360000299, 123360000300, 123360000301, 123360000302, 123360000303, 123360000304, 123360000733, 123360000734, 123360000735, 123360000736, 123360000737, 123360000738, 123360000739, 123360000740, 123360001972, 123360001973, 123360001974, 123360001975, 123360001976, 123360001977, 123360001978, 123360001979, 123360001980, 123360001981, 123350000968, 123350000969, 123350000970, 123350000971, 123350000972, 123350000973, 123350000974, 123350000975, 123350000987, 123350000988, 123350000989, 123350000990, 123350000991, 123350000992, 123350000993, 123350000994, or 123350001032.
  3. Stop using affected traction boots immediately to prevent detachment during surgical procedures.
  4. Contact Baxter Healthcare Corporation at their Deerfield, Illinois headquarters or your local representative for instructions on returning the product for a replacement or repair.
  5. If you have additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

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

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

Affected Products

Product: HDS Traction Boot II
Model / REF:
AR-6529-23
Lot Numbers (80):
123510000293
123510000294
123510000295
123510000296
123510000298
123510000299
123510000300
123510000764
123510000765
123510000766
123510000767
123510000768
123510000769
123510000770
123510000771
123510000772
123510000773
123510000800
123510000801
123510000802
123510000803
123510000804
123510000805
123510000806
123510000807
123510000808
123510000809
123510000297
123350001033
123350001034
123350001035
123350001036
123350001040
123350001041
123350001042
123360000294
123360000295
123360000297
123360000298
123360000299
123360000300
123360000301
123360000302
123360000303
123360000304
123360000733
123360000734
123360000735
123360000736
123360000737

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94202
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: authorized medical distributors
Manufactured In: United States
Units Affected: 80 units
Distributed To: Florida

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.