Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife bran...
FDA Recall #Z-1904-2025 — Class I — May 15, 2025
Product Description
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.
Reason for Recall
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
Recalling Firm
SunMed Holdings, LLC — Grand Rapids, MI
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
9900 eaches
Distribution
US distribution nationwide. International distribution to Canada.
Code Information
UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated