Device product
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.
Z-0099-2014
Product summary
- Event
- Event 66238
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,200 units
- Official record key
device-enforcement:Z-0099-2014
Official wording
Reason: 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.
Code information: UR13C11089, UR13D16060
Distribution pattern: US Distribution including the states of OK, GA, CA, MN, TX and HI.
Derived failure modes
-
Sterility assurance
breach in the sterile barrier