Filled Broselow organizers recalled over potentially harmful dosing errors
SunMed Holdings is recalling 89 units of the Filled Broselow Organizer, model 7730IALS, because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The Filled Broselow Organizer, model/catalog number 7730IALS, is being recalled by SunMed Holdings, LLC. The record describes the Broselow Tape as a length- and weight-based reference tool.
The reason given in the enforcement record is that the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.
The record lists 89 units, with lot or serial numbers and UDI-DI codes recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and Canada, Hong Kong and Singapore. The FDA has classified the action as Class I, its most serious category.
Clinicians should stop using the affected tool for dosing and follow SunMed's instructions.
The recalled product
- Product
- Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.…
- Manufacturer
- SunMed Holdings, LLC
- Affected units
- 89
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by SunMed Holdings, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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