Z-1289-2024Class II

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

Name: Z-1289-2024 STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Creator: Baxter Healthcare Corporation
Published: 2024-02-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-02-14 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 on 2024-02-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1289-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-14
Posted: 2024-03-12
Recalling firm: Baxter Healthcare Corporation
Product: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Product code: FWZ Operating Room Accessories Table Tray
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.
FDA 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 [email protected]. 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 [email protected].
Quantity in commerce: 14 units
Distribution: US Nationwide distribution in the state of Alabama.
Product codes and lots: UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1289-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1289-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-12

Product code FWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)