Baxter Healthcare recalled 18,720 IV solution sets on August 29, 2025, due to a leak hazard. The recall affects devices distributed across the United States, including all 50 states. Patients and healthcare providers should stop using these devices immediately.
IV sets may leak.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions
The recalled product is the CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2.4 m), Product Code: 2H8519. These IV sets were distributed nationwide and are identified by the model UID/DI 00085412625553 and lot number R25C08147.
The IV sets may leak, posing a risk to patients receiving intravenous treatment. Leakage can lead to medication errors or inadequate drug delivery, increasing the risk of adverse health outcomes.
As of the report date, there are no reported injuries or deaths associated with the leakage of these IV sets. The recall is classified as Class II, indicating a potential risk of serious injury.
Stop using the recalled IV sets immediately. Follow the recall instructions provided by Baxter Healthcare or contact your healthcare provider for further guidance.
For more information, contact Baxter Healthcare Corporation. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0204-2026 for detailed instructions.
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