Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-1289-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

Product Classification:

Class II

Date Initiated: February 14, 2024

Date Posted: March 20, 2024

Recall Number: Z-1289-2024

Event ID: 94037

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.

Status: Ongoing

Product Quantity: 14 units

Code Information:

UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314

Distribution Pattern:

US Nationwide distribution in the state of Alabama.

Voluntary or Mandated:

Voluntary: Firm initiated