Medical Device Recall: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Baxter Healthcare Corporation · February 14, 2024
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of Alabama.
States Affected
NATIONWIDE
Quantity Affected
14 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1289-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.