SunMed Holdings, LLC: Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicabl
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- SunMed Holdings, LLC
- 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
- Reason / hazard
- Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
- Recall initiated
- 2025-12-15
- Code info
- Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
- Product quantity
- 384
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Grand Rapids
- State
- MI
- Country
- United States
- Event id
- 98208
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