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.
Enforcement
- Recall Number
- Z-1904-2025
- Event ID
- 96891
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SunMed Holdings, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 2, 2025
- Initiation Date
- May 15, 2025
- Classification Date
- June 20, 2025
- Address
- 2710 Northridge Dr Nw Ste A, Grand Rapids, MI, 49544-9112, United States
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.
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.
UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
US distribution nationwide. International distribution to Canada.
9900 eaches