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FDAFDA · Food and drugs·Recall number Z-0099-2014

Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids.

Published November 6, 2013 · Recall initiated: September 4, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Baxter Healthcare Corp.
Distributor
US Distribution including the states of OK, GA, CA, MN, TX and HI.
Lot
UR13C11089, UR13D16060
Risk classification
Class II
Area (FDA)
device
Country
United States

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