Emergency Response Safety Kit
General, Plastic Surgery · 21 CFR 878.4040
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
28 adverse event reports on file
- AIRLIFE PEDIATRIC BROSELOW TAPESMar 12, 2026MalfunctionSunmed Group Holdings, Llc Dba AirlifeMW5185100
- PRINT VERSION BROSELOW RAINBOW TAPEJan 28, 2026MalfunctionSunmed Group Holdings, Llc Dba AirlifeMW5182946
- BROSELOW RAINBOW TAPEJan 21, 2026InjurySunmed Group Holdings, Llc Dba AirlifeMW5182596
- BROSELOW TAPE VERSION 3Dec 18, 2025MalfunctionSunmed Group Holdings, Llc Dba Airlife23837390
- BROSELOW TAPE 2025 EDITIONDec 17, 2025MalfunctionSunmed Holdings, Llc.MW5180704
- AIRLIFE BROSELOW TAPEDec 10, 2025OtherSunmed Group Holdings, Llc Dba AirlifeMW5180289
- BROSELOW RAINBOW TAPEDec 10, 2025MalfunctionSunmed Group Holdings, Llc Dba AirlifeMW5180294
- BROSELOW PEDIATRIC EMERGENCY REFERENCE TAPEDec 8, 2025MalfunctionAirlife/sunmed Group Holdings, Llc Dba AirlifeMW5180164
- AIRLIFE BROSELOW PEDI EMERGENCY TAPEDec 2, 2025MalfunctionSunmed Group Holdings, Llc Dba AirlifeMW5179692
- BROSELOW 2025 TAPE REV. 3Dec 2, 2025MalfunctionUnknownMW5179701
Event type breakdown
Recalls
5 recall events for this product code
- SunMed Holdings, LLCOpen, ClassifiedJan 28, 2026
Brand Name: Broselow
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Z-1114-2026 · View FDA record ↗ - SunMed Holdings, LLCOpen, ClassifiedJan 28, 2026
Brand Name: Broselow
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Z-1115-2026 · View FDA record ↗ - SunMed Holdings, LLCOpen, ClassifiedJan 28, 2026
Brand Name: Broselow
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Z-1116-2026 · View FDA record ↗ - SunMed Holdings, LLCOpen, ClassifiedJan 28, 2026
Brand Name: Broselow
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Z-1117-2026 · View FDA record ↗ - SunMed Holdings, LLCOpen, ClassifiedJun 20, 2025
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA
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.
Z-1904-2025 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
El Paso, TX, US
Medaire, Inc.
PHOENIX, AZ, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Pediatape
Blacksburg, VA, US
Isomedix Operations Inc
El Paso, TX, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Isomedix Operations Inc
EL PASO, TX, US
Aerospace Accessory Services Inc
Doral, FL, US
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Cardinal Health 200, Llc
Waukegan, IL, US
Legend Aerospace, Inc.
Miami, FL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.