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
123510000293123510000294123510000295123510000296123510000298123510000299123510000300123510000764123510000765123510000766123510000767123510000768123510000769123510000770123510000771123510000772123510000773123510000800123510000801123510000802123510000803123510000804123510000805123510000806123510000807123510000808123510000809123510000297123350001033123350001034123350001035123350001036123350001040123350001041123350001042123360000294123360000295123360000297123360000298123360000299123360000300123360000301123360000302123360000303123360000304123360000733123360000734123360000735123360000736123360000737123360000738123360000739123360000740123360001972123360001973123360001974123360001975123360001976123360001977123360001978
- 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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