Baxter Healthcare Corporation recalled 14,400 units of its Continu-Flo solution set on August 8, 2025. The recall follows customer reports of tubing separation that pose serious risks. Healthcare providers and patients must stop using the device immediately.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
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. Notification method: Letter
The Continu-Flo solution set features two Clearlink Luer activated valves and a backcheck valve. It has a length of 112 inches (2.8 m) and is identified by product code REF 2C8519.
The tubing separation can lead to serious complications during intravascular administration. This recall has been classified as Class II, indicating a potential risk of injury.
Baxter received multiple reports of tubing separation, but specific incident counts have not been disclosed. No injuries or deaths have been reported at this time.
Patients and healthcare providers should stop using the device immediately. Contact Baxter Healthcare or your healthcare provider for guidance on the recall.
For further information, call Baxter Healthcare Corporation at 1-800-XXX-XXXX or visit their website.
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