[pending] Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-1116-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
The recalled product
- 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.
- Manufacturer
- SunMed Holdings, LLC
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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