Baxter Healthcare Corp. recalled 12,720 CLEARLINK SYSTEM CONTINU-FLO IV sets distributed nationwide to healthcare facilities. The devices may leak during use. Hospitals and clinicians should stop using immediately and follow Baxter's recall instructions.
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
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The CLEARLINK SYSTEM CONTINU-FLO IV set is used to administer intravenous fluids in clinical settings. It features three Luer Activated Valves and a Backcheck Valve in a non-vented design.
Leakage in IV sets can compromise sterile delivery and fluid administration during patient care. The leak could require device replacement and interrupt treatment.
This recall is not identified as part of a broader industry pattern in the provided data.
Hospitals may need to halt use of affected lots and replace devices, potentially impacting patient care workflows and supplier logistics.
Recall notice on FDA enforcement page and Baxter's recall communications.
Refunds or replacements are typically processed within 4-8 weeks after verification.
Retain recall notices, purchase records, device labeling, UDI, and all correspondence related to the recall.
Product Code: 2R8537. UDI/DI: 00085412565743. Lot numbers: R25C28048. Distribution: Nationwide in the United States. Sold through: Healthcare facilities and providers. Quantity: 12,720 units. Price: Unknown.
No injuries or incidents have been reported.
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