Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36
Summary
The FDA issued a Class I for Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA by SunMed Holdings, LLC. 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. U.
Details
Source
Device Recall
External ID
Z-1904-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
Quantity Affected: 9900 eaches
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
US distribution nationwide. International distribution to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-15
Company
Grand Rapids, MI
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SunMed Holdings, LLC has 18 FDA actions in our database, including 18 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SunMed Holdings, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SunMed Holdings, LLC have FDA actions?
SunMed Holdings, LLC has 18 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1904-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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