ALLEN recallZ-1289-2024 · Baxter Healthcare Corporation · initiated Feb 14, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-1289-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 14, 2024
- Posted by the FDA
- Mar 12, 2024
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 14 units
- Product code
- FWZ
- Distribution
- US Nationwide distribution in the state of Alabama.
Product description
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Code information (models, lots, serial numbers)
UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
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Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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