FDAHealthDecember 15, 2025
SunMed Holdings, LLC — Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow
⚠️ Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 15, 2025
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
What's affected?
- 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
- Brand
- SunMed Holdings, LLC
- Lot code
- Lot/Serial
Additional details
Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 95300.
Get Health recall alerts
Delivered to your inbox. Free. No account required.