STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
This recall is currently active, issued March 12, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- February 14, 2024
- Posted
- March 12, 2024
- Recall Number
- Z-1289-2024
- Quantity
- 14 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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
US Nationwide distribution in the state of Alabama.
Lot / Code Info
UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
Root Cause
Under Investigation by firm
Action Taken
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.