Z-1289-2024 Class II Ongoing
FDA device recall Z-1289-2024 was initiated by Baxter Healthcare Corporation on Feb 14, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2024
- Initiation Date
- Feb 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
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 Pattern
US Nationwide distribution in the state of Alabama.
Code Information
UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1289-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026