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
USBrand 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
Recalling Firm: SunMed Holdings, LLC
Reason for Recall / Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Product Description & Identification
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
Affected Products
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
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) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151 |
| Postal code | 49544-9112 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 384 |
| 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 |
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Overview
- Recalling FirmSunMed Holdings, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
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🚨 SAFETY ALERT: SunMed Holdings, LLC - 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 Check if your household is affected: https://therecallfile.com/recalls/brand-name-broselow-product-name-broselow-domestic-complete-als-organi/FDA-Z-1116-2026
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