FDAFDA · Food and drugs·Recall number Z-1289-2024
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Published March 20, 2024 · Recall initiated: February 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide distribution in the state of Alabama.
- Lot
- UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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