Device product
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS 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-1116-2026
Product summary
- Event
- Event 98208
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 384
- Official record key
device-enforcement:Z-1116-2026
Official wording
Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Code information: Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Derived failure modes
-
Unknown
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.