FDA Device recall Z-1904-2025
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife)
- FDA Device
- Class I
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class I recall of Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) by Sunmed Holdings, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1904-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-15 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sunmed Holdings |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1904-2025%22
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