STERIS Boot Assembly, Traction Device Recalled Due to Locking Pin Detachment Risk
Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with structural defect that could cause patient harm during surgery. No illnesses, injuries, or hospitalizations have been reported. Per rubric, risk-of-harm products without reported injury qualify as High severity (score 3).
Plain-English summary
Baxter Healthcare Corporation is recalling the STERIS Boot Assembly, Traction Device, OT 1000 (Part Number REF 10009192). The device is a traction mechanism used during surgical procedures.
A customer reported that an incorrectly oriented locking pin caused the boot to detach from the traction system. If the affected device is used during surgery, the boot may detach from the traction system, potentially causing patient harm and delaying surgical procedures.
Affected product includes lot numbers 23-140, 23-268, and 23-314 (UDI/DI 00615521000851). The recalled units were distributed nationwide with presence in Alabama.
Healthcare facilities should verify whether they have any of the affected lot numbers in use and contact Baxter Healthcare Corporation immediately with any questions.
The recalled product
- Product
- STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- equipment-defect
- detachment
- surgical-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 00615521000851
- Lot Numbers: 23-140
- 23-268
- 23-314
Distribution
Distributed nationwide across the United States.
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