Z-0099-2014 Class II Terminated
FDA device recall Z-0099-2014 was initiated by Baxter Healthcare Corp. on Sep 4, 2013 and is designated Class II. 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. The recall status is terminated (terminated Apr 19, 2017). Affected quantity: 3,200 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 6, 2013
- Initiation Date
- Sep 4, 2013
- Termination Date
- Apr 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,200 units
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.
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.
Distribution Pattern
US Distribution including the states of OK, GA, CA, MN, TX and HI.
Code Information
UR13C11089, UR13D16060
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0099-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026