FDAHealthDecember 15, 2025
SunMed Holdings, LLC — Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS 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 Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS 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) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 384.
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