—#206177

Product

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

FDA product code: FWZ — Operating Room Accessories Table Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Baxter issued an Urgent Medical Device Recall notice to its sole consignee on 02/14/2024. The notice explained the the problem with the device, potential risk and requested the following actions be taken: Locate, isolate, and cease all use of the affected product and arrange for the return of the affected units calling the Baxter Order Management Team at 800-433-5774, option 2 then 3, between the hours of 8:00 am and 5:00 pm Eastern Time, Monday through Friday, or emailing Baxter at hrc_amatech_orders@baxter.com. If the product was distributed to other facilities or departments within an institution, please forward a copy of this communication to them. Dealers, wholesalers, distributor/resellers, or original equipment manufacturers (OEM) that distributed any affected product to other facilities, are asked to conduct a consumer-level recall of the affected product. For general questions regarding this communication, please contact the Baxter Order Management Team by phone at 800-433-5774, option 2 then option 3, between the hours of 8:00 am and 5:00 pm Eastern Time, Monday through Friday, or by email at hrc_amatech_orders@baxter.com.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution in the state of Alabama.

Timeline

Recall initiated: 2024-02-14
Posted by FDA: 2024-03-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206177. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.