SunMed Holdings, LLC recalls Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife)

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.

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.

On May 15, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were given detailed information about the incorrect information printed on the tape. Customers were instructed to identify and quarantine all affected product in inventory. Customers should destroy and dispose of all affected product. If product was further distributed, distributors should identify their customers/consignees and notify them of the recall. The firm will provide replacement products once customer confirms destruction of affected product.

• FDA enforcement recordOfficial FDA database entry for Z-1904-2025
• FDA device classification · OKIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SunMed Holdings, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.