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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Event Detail

Event ID 66238
Product Type Devices
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-04
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution including the states of OK, GA, CA, MN, TX and HI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. UR13C11089, UR13D16060 Class II 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. 3,200 units Z-0099-2014