ICU Medical recalled 23,203 IV administration sets on October 2, 2025. The sets lack an internal shutoff valve, risking fluid over-delivery and air infusion. This recall affects devices distributed worldwide, including the U.S., Canada, Australia, and New Zealand.
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
The recalled products include multiple models: REF B33359, B9213, B9732, B9733, and 011-C7014. These devices were distributed from various healthcare suppliers. The price is not specified.
The absence of an internal shutoff valve can lead to unintended fluid flow, resulting in potential delays in therapy or air infusions. This malfunction presents a high risk to patient safety.
There have been no reported incidents or injuries related to this recall as of the report date. However, the potential risks are significant.
Stop using the recalled IV administration sets immediately. Contact ICU Medical, Inc. or your healthcare provider for further instructions.
For more information, contact ICU Medical at [insert phone number] or visit their website at [insert website].
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