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Recall Observatory FDA recall evidence

Device 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

Z-1115-2026

December 15, 2025

Class I

Product summary

Firm
SunMed Holdings, LLC
Event
Event 98208
Status
Ongoing
Classification
Class I
Quantity
20583
Official record key
device-enforcement:Z-1115-2026

Official wording

Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

Code information: Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.