Broselow Pediatric Emergency Tape recalled for incorrect dosing information
SunMed's Broselow pediatric emergency tape has incorrect dosing information printed in critical zones. Using these incorrect values could cause cardiac arrest, burns, and serious electrolyte imbalances during emergency care.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4. While the defect could cause serious harm including cardiac arrest, burns, and critical metabolic disturbances, no deaths or injuries are reported in the recall notice, preventing a higher score.
Plain-English summary
The U.S. Food and Drug Administration is recalling Broselow Pediatric Emergency Rainbow Tape (AirLife brand, REF 7700REA, 2025 Edition) manufactured by SunMed Holdings, LLC. The tape was manufactured with incorrect information printed in critical zones, affecting approximately 9,900 units distributed nationally in the U.S. and internationally to Canada.
The tape contains incorrect dosing values in the Red, Orange, and Grey zones. Using the incorrect values in the Red zone could deliver an excessive electrical shock dose, potentially causing burns, heart damage, and cardiac arrest. The incorrect Orange zone information could lead to sodium bicarbonate overdose, resulting in metabolic alkalosis, electrolyte imbalances, tissue damage, and respiratory deterioration. Incorrect Grey zone information could cause sodium bicarbonate underdose, potentially reducing heart muscle function, decreasing response to vasopressor medications, and increasing the risk of abnormal heart rhythms.
The Broselow Pediatric Emergency Rainbow Tape is a length- and weight-based reference tool used in pediatric emergency care settings to determine appropriate medication dosing based on patient length and weight.
The recalled product
- Product
- Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
- Manufacturer
- SunMed Holdings, LLC
- Hazard
- mis-labeling
- cardiac-arrest
- burn-injury
- electrolyte-imbalance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
Distribution
Distributed nationwide across the United States.
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