Class II — Baxter Healthcare Corp.
| Recalling firm | BAXTER HEALTHCARE CORPORATION |
|---|---|
| Registered facility | View this company's 32 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 3,200 units |
| Distribution | US Distribution including the states of OK, GA, CA, MN, TX and HI. |
| Initiated | 2013-09-04 |
| Classified | 2013-10-29 |
| Terminated | 2017-04-19 |
| Recall number | Z-0099-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Baxter Healthcare Corp. (Z-0099-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66238/
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