FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
- Recall number
- Z-1289-2024
- Recalling firm
- Baxter Healthcare Corporation
- Product
- STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
- Status
- Open, Classified
- Initiated
- 2024-02-14
- Posted
- 2024-03-12
- Terminated
- not on file
- 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 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.
- Quantity
- 14 units
- Distribution
- US Nationwide distribution in the state of Alabama.
- Lot, serial or model codes
- UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FWZ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28