This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
What to Do
On May 15, AirLife sent all affected customers a letter recommending the following actions:
- Examine your inventory for affected product.
- Quarantine all affected product in inventory.
- Immediately stop use of affected product or product that has been removed from the outer bulk labeling (e.g. included on a Broselow Color-code Cart) with version “AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version.”
- If you have further distributed this product, please identify your customers/consignees and notify them of this product removal.
- Please make sure that all affected personnel in your organization are informed of this removal notice.
Reason for Recall
AirLife stated that certain lots of Broselow Rainbow Tapes have been manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone.
Incorrect joules in the cardioversion and defibrillation section are printed in the Red zone of the tape. Using the incorrect information in this section for cardioversion and defibrillation could lead to shocking a patient with an excessive dose of joules, causing potential significant harm including burns, heart damage, and cardiac arrest.
Incorrect sodium bicarbonate concentration information is printed in the Orange zone of the tape. Using the incorrect information in this section may lead to overdosing the patient and may cause metabolic alkalosis, electrolyte imbalances, tissue damage, and potentially worsen respiratory status.
Incorrect sodium bicarbonate concentration information is printed in the Grey zone of the tape. Using the incorrect information in this section may lead to underdosing the patient and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
AirLife has not reported any serious injuries or deaths associated with this issue.
Device Use
The Broselow Rainbow Tape is a color-coded length-based tape measure. A child's height, measured on the tape, corresponds to a color zone and a weight range. This color zone provides pre-calculated information for medication dosages, equipment sizes, and other relevant emergency procedures. It reduces the time needed to calculate dosages and equipment sizes in a critical emergency.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact AirLife at productquality@myairlife.com or 1-800-433-2797.
Additional FDA Resources (listed in order of most to least recent):
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
