The FDA has issued an early alert regarding a potentially high-risk device issue with the Broselow Rainbow Tape, a color-coded length-based tape used in pediatric emergencies. This alert is crucial for healthcare professionals and organizations that utilize this device.
What Changed?
AirLife, the manufacturer, has identified a version of the Broselow Rainbow Tape with incorrect medication-related information. The affected product is the 2025 Edition, with the reference number 36-23446 Rev 3 Print Version, and is branded with the AirLife logo.
Affected Product and Actions
The FDA recommends immediately identifying, ceasing use, and discarding the affected product. Healthcare facilities should check their inventory and clinical areas for the affected tapes and remove them from service to prevent further use. It is also essential to notify all clinicians and healthcare professionals within the organization about this recall and ensure they understand that the affected tapes must not be used.
Medication Errors
The affected product contains three medication-related errors: Vecuronium, Flumazenil, and Ketamine (IV/IO for pain/analgesia). These errors can lead to serious or life-threatening clinical consequences, including hypoxia, failed or delayed intubation, seizures, withdrawal symptoms, and respiratory depression or apnea.
Implications and Next Steps
Healthcare professionals and consumers should report any adverse reactions or quality problems experienced with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Additionally, customers in the U.S. with questions about this issue should contact AirLife at productquality@myairlife.com or 1-800-433-2797.
Conclusion
In conclusion, the FDA’s early alert regarding the Broselow Rainbow Tape is a critical notification for healthcare professionals and organizations. It is essential to take immediate action to identify and discard the affected product to prevent potential harm to patients. By understanding the medication errors and taking the recommended steps, healthcare professionals can ensure the safe use of medical devices in pediatric emergencies.
Disclaimer
This information is not intended to be legal advice. Healthcare professionals should consult the FDA’s official resources and seek guidance from regulatory experts as needed.
FDA Announcement
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-broselow-rainbow-tape-issue-airlife