STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Baxter Healthcare Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Product Codes/Lot Numbers:
UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1289-2024
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