Broselow pediatric rainbow tape recalled for potential dosing errors
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.
From the FDA notice · Read the official notice ↗
What to do
- 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
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: 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
- Sold in
- Nationwide
- Made for
- Children (under 12 years)
This recall covers 4 products — see all of them.
Details
- Units affected
- 20583
- 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-1115-2026
In the FDA's words
- Description
- 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 Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967 Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. Affected quantity: 20583
- 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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