Serious riskFDA DeviceClass I

Broselow pediatric rainbow tape recalled for potential dosing errors

The Broselow Tape, a tool used in pediatric emergencies to calculate medication doses based on a child's length and weight, contains incorrect dosing information for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to wrong doses being given during emergency care. The FDA has classified this as a Class I recall, the most serious category.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using the affected Broselow Tape immediately if you have one in your facility
  2. Check if your tape's lot number matches the list provided by the FDA
  3. Contact SunMed Holdings or your medical supplier for a replacement or corrected version
  4. Notify your clinical staff and emergency team about this recall

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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
Sold in
Nationwide
Made for
Children (under 12 years)

This recall covers 4 products — see all of them.

Details

Units affected
95300
Illnesses reported
None reported
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Classification
Class I
Recall number
Z-1114-2026

In the FDA's words

Description
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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 Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974 Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. Affected quantity: 95300
Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

4 products in this recall

Broselow pediatric emergency tapes recalled for drug dosing errors

SunMed is recalling four Broselow pediatric emergency products, including Rainbow Tapes and ALS organizers, because they may contain dosing errors for the drugs vecuronium, flumazenil, and ketamine. The FDA has classified this as a Class I recall, its most serious category. The products were distributed in the US nationwide, Canada, Hong Kong, and Singapore, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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