Broselow Pediatric Emergency Rainbow Tape recalled for incorrect dosing values
SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape due to incorrect values printed on the tape that could lead to improper medication dosing and defibrillation in pediatric emergency care.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device. The source text explicitly describes serious harms that could result from incorrect dosing values, including cardiac arrest, burns, heart damage, metabolic alkalosis, and dysrhythmias, which meet the threshold for severe patient impact.
Plain-English summary
SunMed Holdings, LLC is recalling the Broselow Pediatric Emergency Rainbow Tape (REF 7700REA, AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version, Lot 0004316661) due to incorrect information printed on the tape. The tape is a length- and weight-based reference tool designed for pediatric emergency care.
The impacted tape was manufactured with incorrect values printed in the Red zone, Orange zone, and Grey zone. Using the incorrect Red zone values could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect Orange zone values could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect Grey zone information may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
The product was distributed nationwide in the US and internationally to Canada. Patients and healthcare providers using this tape should immediately discontinue use and contact SunMed Holdings, LLC for corrected replacement materials or consult with their healthcare facility for proper procedures during pediatric emergencies.
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
- Affected units
- 9,900
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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