Recall Z-1289-2024 ยท FWZ Operating Room Accessories Table Tray
Baxter Healthcare Corporation
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
| Date | Mar 12, 2024 (initiated Feb 14, 2024) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by firm |
| Action | 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 ins |
| Quantity | 14 units |
| Distribution | US Nationwide distribution in the state of Alabama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.