STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Summary
The FDA issued a Class II for STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 by Baxter Healthcare Corporation. 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 cause.
Details
Source
Device Recall
External ID
Z-1289-2024
Action Date
2024-03-20
Status
Ongoing
Category
device
Product Description
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Lot/Code Info: UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
Quantity Affected: 14 units
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.
Distribution
US Nationwide distribution in the state of Alabama.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-14
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1289-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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