Reported Mar 27, 2024 · Ongoing

HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's…

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
Lot codes and dates
  • 80 of 80 codes

    • 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
Amount recalled
80 units

Where it was sold

  • Nationwide
  • FL

Why it was recalled

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.