FDA recall Z-1114-2026

SunMed Holdings, LLC · Class I · device

Product

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-12-15
Report date
2026-02-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2026