FDA-Device2026-02-04Class IMISBRANDING
Broselow Pediatric Emergency Rainbow Tape recalled for dosing errors in three medications
What this means
SunMed Holdings is recalling certain Broselow Pediatric Emergency Rainbow Tapes because they contain incorrect dosing information for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to wrong drug doses during pediatric emergency care. This is a serious safety issue affecting emergency departments and medical facilities.
- Check if your facility has Broselow Tape model 7700RE with any of the listed lot numbers (0004325583, 0004329077, 0004329078, 0004329079, 0004331255, 0004333368, 0004335537, 0004338439, 0004340824)
- Stop using affected tapes immediately
- Contact SunMed Holdings or your medical equipment supplier for a replacement or corrected version
- Alert your emergency medicine team and pharmacy about this recall
The agency's original wording
Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Intended for
Children (under 18 years)
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Affected count
20583
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Products
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1115-2026Want us to check the next one for you?
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