ICU Medical recalls 23,203 IV gravity burette sets worldwide. The burette component is missing an internal shutoff valve, which can delay therapy, cause overdelivery, or allow air to be infused. Stop using the device and contact ICU Medical for instructions.
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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IV gravity burette sets deliver measured IV fluids in controlled volumes for patient care in hospital settings. They come in multiple lengths and configurations to fit clinical workflows.
A missing internal shutoff valve in the burette component can create delays in therapy, permit overdelivery, or allow air to be infused into a patient.
This recall is not stated to be part of a broader industry pattern.
Hospitals may experience workflow disruptions and potential patient safety risks if affected sets are used. Facilities should remove the recalled devices from service and follow replacement instructions.
Recall details are on ICU Medical’s site and the FDA enforcement page. Look for model numbers and lot codes on device labeling.
Replacement or remediation timelines vary; expect several weeks for processing.
Keep recall notice, model/REF codes, lot numbers, purchase records, and correspondence with ICU Medical.
Model numbers/references: B33359; B9213; B9732; B9733; 011-C7014; 14065820; 14110075; 14211300; 14129823; 14126963; 14130197. Distribution: Worldwide distribution including the US nationwide and in TX and SC; Canada, Australia, New Zealand. Quantity recalled: 23,203 units. Brand: ICU Medical. Product: IV gravity burette sets with 150 mL burettes, various configurations (Clave, Shut-Off, MicroClave, 3-Way Stopcock, Rotating Luer, etc.). Recall date: 2025-10-02. Status: ACTIVE.
No injuries or incidents have been reported.
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