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Recall Observatory FDA recall evidence

Device 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

Z-1114-2026

December 15, 2025

Class I

Product summary

Firm
SunMed Holdings, LLC
Event
Event 98208
Status
Ongoing
Classification
Class I
Quantity
95300
Official record key
device-enforcement:Z-1114-2026

Official wording

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

Code information: Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974

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.