Baxter Healthcare Corporation STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
Products Sold
UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
Baxter Healthcare Corporation is recalling STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 due to 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 cause. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
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