FDA DevicesClass I
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape M...
Published: February 4, 2026Recall ID: Z-1115-2026Category: devicesCountry: US
Reason for Recall / Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Grand Rapids |
| State | MI |
| Event id | 98208 |
| Address 1 | 2710 Northridge Dr Nw Ste A |
| Address 2 | N/A |
| Code info | Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967 |
| Postal code | 49544-9112 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 20583 |
| Reason for recall | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Letter |
| Center classification date | 20260128 |
Overview
- Recalling FirmSunMed Holdings, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.