Z-1904-2025Class I

Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition...

Name: Z-1904-2025 Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition...
Creator: SunMed Holdings, LLC
Published: 2025-05-15
License: https://open.fda.gov/license/

Salter Labs / initiated 2025-05-15 / Open, Classified / root cause: manufacturing process

FDA source

SunMed Holdings, LLC began a recall of Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow... on 2025-05-15. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1904-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-05-15
Posted: 2025-06-20
Recalling firm: Salter Labs
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.
Product code: OKI Emergency Response Safety Kit
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 9900 eaches
Distribution: US distribution nationwide. International distribution to Canada.
Product codes and lots: UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1904-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1904-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-20

Product code OKI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)