Broselow filled organizer recalled for potential drug dosing errors
The Broselow Tape, a tool used in pediatric emergency care to determine medication doses based on a child's length and weight, contains dosing errors for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to incorrect doses being given in emergency situations. The affected units have specific lot numbers and are distributed in the US, Canada, Hong Kong, and Singapore.
From the FDA notice · Read the official notice ↗
What to do
- Check if your facility has Broselow Tape with lot numbers 0004317699, 0004333171, or 0004333593
- Stop using affected units immediately
- Contact SunMed Holdings or your supplier for instructions on replacement or correction
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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
- Sold in
- Nationwide
- Made for
- Children (under 12 years)
This recall covers 4 products — see all of them.
Details
- Units affected
- 89
- Illnesses reported
- None reported
- Manufactured in
- 2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
- Classification
- Class I
- Recall number
- Z-1117-2026
In the FDA's words
- Description
- Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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 Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209 Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. Affected quantity: 89
- Hazard
- Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
4 products in this recall
Broselow pediatric emergency tapes recalled for drug dosing errors
SunMed is recalling four Broselow pediatric emergency products, including Rainbow Tapes and ALS organizers, because they may contain dosing errors for the drugs vecuronium, flumazenil, and ketamine. The FDA has classified this as a Class I recall, its most serious category. The products were distributed in the US nationwide, Canada, Hong Kong, and Singapore, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Descr…Z-1114-2026 · 95300
- Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Descri…Z-1115-2026 · 20583
- Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Descri…Z-1116-2026 · 384
- Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Descriptio… (this page)Z-1117-2026 · 89