FDA Device recall Z-1289-2024
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
- FDA Device
- Class II
- ongoing
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1289-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-14 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
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.
Identifiers
| code_info | UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1289-2024%22
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