Recall Z-1117-2026— SunMed Holdings, LLC
Class I · Ongoing
Class I FDA medical device recall by SunMed Holdings, LLC, initiated 2025-12-15. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine..
- Recalling firm
- SunMed Holdings, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-12-15
- Firm location
- Grand Rapids, MI, United States
Product 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
Reason for recall
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Data sourced from openFDA. This site is unofficial and independent of the FDA.