STERIS Boot Assembly recall
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Why was STERIS Boot Assembly 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
- Product
- STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 14 units
- Distribution
- US Nationwide distribution in the state of Alabama.
- Recall date
- March 20, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)