The FDA has announced a critical recall concerning ICU Medical Inc.’s IV Gravity Burette Sets, which are used for intravascular fluid administration. Clinical, quality, and regulatory professionals must urgently act to mitigate risks associated with this device, as its use may lead to severe injuries or even death.
What changed?
On October 2, 2025, ICU Medical notified customers of an immediate recall of specific IV Gravity Burette Sets. The recall affects devices missing the essential internal blue shut-off valve within the burette chamber. This omission compromises the safety of the devices, as it eliminates crucial functionalities that control fluid flow.
Why is this critical?
The FDA has classified this recall as the most serious type due to the potential for life-threatening harm. Missing shut-off valves could lead to:
- Over-delivery of fluids or unrestricted flow.
- Infusion of air into a patient’s bloodstream.
- Delays in therapy delivery.
- Severe injuries or fatalities.
Although no injuries or deaths have been reported as of September 25, proactive measures are vital to avoid adverse outcomes.
Who is affected?
This recall applies to healthcare institutions, medical professionals, and distributors who use or stock the affected ICU Medical IV Gravity Burette Sets. Any parties handling administration sets used for vascular fluid infusion should check their inventory for affected devices.
What actions should you take?
ICU Medical has recommended the following steps for all affected parties:
- Immediately discontinue use of the impacted devices.
- Identify and destroy or quarantine affected products according to institutional protocols.
- Ensure that this recall notification reaches all potential users of the device within your institution or affiliated locations.
Healthcare providers and institutions should also utilize the FDA’s Medical Device Enforcement Report and Recall Database to confirm specific recalls and actions.
Understanding device use
Administration sets like the IV Gravity Burette Sets are pre-sterilized medical devices designed for single use. These products facilitate the delivery of fluids from a container to a patient’s vascular system using intravenous equipment, such as needles or catheters.
The manufacturing process may generate products sold individually or incorporated into larger sets or trays distributed by other companies.
Contact information
If you have questions regarding this recall, ICU Medical’s customer service team can assist:
- Phone: 1-800-258-5361
- Email: customerservice@icumed.com
For adverse events or issues related to these devices, healthcare professionals and consumers can make reports through FDA MedWatch by visiting MedWatch Safety and Adverse Event Reporting Program.
Conclusion
This recall underscores the importance of verifying device functionality to protect patient safety. By promptly identifying and discontinuing use of affected devices, healthcare professionals can play a critical role in preventing harm and improving device accountability.
Disclaimer
This article is intended for informational purposes only and does not constitute legal advice. Readers are advised to consult their institution or legal counsel for compliance actions.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/intravascular-administration-set-recall-icu-medical-removes-iv-gravity-burette-set