Baxter Healthcare Corp.: Medical Device Recall in 2013 - (Recall #: Z-0099-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: September 4, 2013
Date Posted: November 6, 2013
Recall Number: Z-0099-2014
Event ID: 66238
Reason for Recall:

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.

Status: Terminated
Product Quantity: 3,200 units
Code Information:

UR13C11089, UR13D16060

Distribution Pattern:

US Distribution including the states of OK, GA, CA, MN, TX and HI.

Voluntary or Mandated:

Voluntary: Firm initiated