Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve
Summary
The FDA issued a Class I for Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape M by SunMed Holdings, LLC. Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine..
Details
Source
Device Recall
External ID
Z-1115-2026
Action Date
2026-02-04
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967
Quantity Affected: 20583
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-15
Company
Grand Rapids, MI
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SunMed Holdings, LLC has 18 FDA actions in our database, including 18 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SunMed Holdings, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SunMed Holdings, LLC have FDA actions?
SunMed Holdings, LLC has 18 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1115-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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