SunMed Holdings recalled 95,300 units of Broselow Pediatric Emergency Rainbow Tape on December 15, 2025. The tape contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Patients and healthcare providers must stop using the product immediately.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SunMed Holdings, LLC or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Broselow Pediatric Emergency Rainbow Tape, model number 7700REA. It was distributed worldwide, including the United States, Canada, Hong Kong, and Singapore.
The Broselow Tape has been found to contain dosing errors for critical medications used in pediatric emergency care. These errors pose a high risk of adverse effects for patients.
To date, there have been no reported injuries or deaths associated with the use of the defective tape. However, the potential for serious harm exists due to incorrect dosages.
Patients and healthcare providers should stop using the Broselow Tape immediately. Contact SunMed Holdings or your healthcare provider for further instructions and to follow the recall process.
For more information, contact SunMed Holdings, LLC at their customer service line or visit the official recall page provided by the FDA.
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