SunMed Holdings, LLC: Device Recall

Recall Details

Recall Number

Z-1115-2026

Classification

Class I

Product Type

Device

Recalling Firm

SunMed Holdings, LLC

Status

Ongoing

Date Initiated

12/15/2025

Location

Grand Rapids, MI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

20583

Reason for Recall

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

Product Description

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

Other Recalls by SunMed Holdings, LLC

• Class I: Dangerous 12/15/2025
  Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
• Class I: Dangerous 12/15/2025
  Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
• Class I: Dangerous 12/15/2025
  Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
• Class I: Dangerous 05/15/2025
  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.
• Class I: Dangerous 05/01/2025
  Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

View all recalls by SunMed Holdings, LLC →