SunMed Holdings, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
SunMed Holdings, LLC
Lot Codes / Batch Numbers
UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
Products Sold
UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
SunMed Holdings, LLC is recalling Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 20 due to The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. U. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 15, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were given detailed information about the incorrect information printed on the tape. Customers were instructed to identify and quarantine all affected product in inventory. Customers should destroy and dispose of all affected product. If product was further distributed, distributors should identify their customers/consignees and notify them of the recall. The firm will provide replacement products once customer confirms destruction of affected product.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
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