Baxter CLEARLINK System Non-DEHP Three Lead Extension Set — Class II medical device recall Z-0099-2014
Terminated recall by Baxter Healthcare Corp., reported 2013-11-06, distributed in CA, GA, HI, MN, OK, TX. The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a brea
| Recall number | Z-0099-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-09-04 |
| Classified | 2013-10-29 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2017-04-19 |
| Distributed | CA, GA, HI, MN, OK, TX |
| Quantity | 3,200 units |
| Reason classes | sterility |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.