FDAFebruary 14, 2024device
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Ongoing
Brands named
baxter healthcarebaxter
UPCs
00615521000851
Recall history
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