Home / Recalls / Medical Devices
Baxter Healthcare Corporation recalls STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Recalled March 20, 2024 · FDA recall Z-1289-2024 · Baxter Healthcare
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. · FDA Class II
Units
14 units
Sold at
US Nationwide distribution in the state of Alabama.
Description
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.
Product
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →