Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife bran...
FDA Device Recall #Z-1904-2025 - Class I, May 15, 2025
Recall Summary
| Recall Number | Z-1904-2025 |
| Classification | Class I - Serious risk |
| Date Initiated | May 15, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | SunMed Holdings, LLC |
| Location | Grand Rapids, MI |
| Product Type | Devices |
| Quantity | 9900 eaches |
Product Description
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Reason for Recall
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
Distribution Pattern
US distribution nationwide. International distribution to Canada.
Lot / Code Information
UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
Other Recalls from SunMed Holdings, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1116-2026 | Class I | Brand Name: Broselow Product Name: Broselow Do... | Dec 15, 2025 |
| Z-1117-2026 | Class I | Brand Name: Broselow Product Name: BROSELOW" F... | Dec 15, 2025 |
| Z-1115-2026 | Class I | Brand Name: Broselow Product Name: Broselow Pe... | Dec 15, 2025 |
| Z-1114-2026 | Class I | Brand Name: Broselow Product Name: Broselow Pe... | Dec 15, 2025 |
| Z-1814-2025 | Class I | Adult Manual Resuscitator with Medium Adult Mas... | May 1, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.