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
Publicado el 27 de marzo de 2024 · Inicio del retiro: 11 de marzo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Baxter Healthcare Corporation
- Distribuidor
- US Nationwide distribution in the state of Florida.
- Lote
- 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, 123350001032
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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