SunMed Broselow Tape Recall - Class I
Summary
The FDA has issued a Class I recall for SunMed Holdings' Broselow Pediatric Emergency Rainbow Tape due to potentially harmful dosing errors for specific medications. The recall affects worldwide distribution, including the US, Canada, Hong Kong, and Singapore.
What changed
The FDA has classified a recall for SunMed Holdings' Broselow Pediatric Emergency Rainbow Tape as Class I, indicating a serious health risk. The recall stems from identified dosing errors for Vecuronium, Flumazenil, and Ketamine when using the tape, which is designed to assist in pediatric emergency dosing.
Healthcare providers and facilities that have distributed or used this product must immediately stop using it and quarantine any remaining stock. The FDA urges prompt action to prevent potential patient harm due to incorrect medication dosages. The recall is ongoing and affects distribution worldwide, including the United States.
What to do next
- Stop using the Broselow Pediatric Emergency Rainbow Tape.
- Quarantine any remaining product stock.
- Notify relevant parties about the recall.
Source document (simplified)
SunMed Holdings, LLC
Device Recalls (Class I)
← All Device Recalls (Class I) Class I Z-1115-2026 · 20260204 · Ongoing
Product
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- an...
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.
Source: openFDA Enforcement API
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