FDA-Device2024-03-20Class II
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Baxter Healthcare Corporation
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.
Sold states
US Nationwide distribution in the state of Alabama.
Affected count
14 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2024Don't want to check this manually?
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