Baxter Healthcare recalls STERIS Boot Assembly, Traction Device (OT 1000) due to a locking pin issue that may cause detachment during surgery, risking patient harm and surgery delays.
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.
Baxter Healthcare is recalling STERIS Boot Assemblies for traction devices because a faulty locking pin could cause the boot to detach during surgery. This poses a risk of patient harm and surgery delays if the device is used without correction.
The locking pin is incorrectly oriented in some units, causing the boot to detach from the traction system during surgery. This could lead to patient harm and delays in critical medical procedures.
Surgical teams using the STERIS Boot Assembly, Traction Device (OT 1000) with specific lot numbers are affected. Patients undergoing surgery with this device are at risk if the boot detaches.
Check for the part number REF 10009192 and lot numbers 23-140, 23-268, or 23-314 on the device. The product was sold with UDI/DI 00615521000851.
Identify the lot number on the device to confirm if it is one of the recalled lots: 23-140, 23-268, or 23-314.
The recall is due to a customer report of an incorrectly oriented locking pin that can cause the boot to detach from the traction system during surgery, potentially causing patient harm and surgery delays.
Check the lot number on the device. If it matches the recalled lots (23-140, 23-268, or 23-314), contact Baxter Healthcare for instructions.
The recall record does not specify a remedy, so no immediate fix is provided. Affected users should contact Baxter Healthcare for further guidance.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1289-2024 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1289-2024 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
