SunMed Holdings, LLC: Device Recall

Recall #Z-1904-2025 · 05/15/2025

Class I: Dangerous

Recall Details

Recall Number
Z-1904-2025
Classification
Class I
Product Type
Device
Recalling Firm
SunMed Holdings, LLC
Status
Ongoing
Date Initiated
05/15/2025
Location
Grand Rapids, MI, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9900 eaches

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.

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.

Distribution Pattern

US distribution nationwide. International distribution to Canada.

Other Recalls by SunMed Holdings, LLC

View all recalls by SunMed Holdings, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.