Recall Z-1289-2024— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-02-14. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-14
- Firm location
- Deerfield, IL, United States
Product description
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.