Pediatric ALS organizers recalled over potentially harmful drug dosing errors
SunMed Holdings is recalling 384 units of the Broselow Domestic Complete ALS Organizer because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 Broselow Domestic Complete ALS Organizer, model/catalog number 7730ALS, 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 384 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
- SOMA KITCHEN NATURAL ASAFOETIDA Net Wt. 4 oz (0.25 lb) Product of India Manufactured for and Imported by: Bharat Bazar, Fremont, CA 94539 Use by : JULY-2027 Lot : NATL/ASFTP/G/24 (BB/ASFTP/G/24) UPC : 4 973993 173586 Ingredients :- Natural Hing
- Manufacturer
- BHARAT BAZAR
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Use by : JULY-2027 Lot : NATL/ASFTP/G/24 (BB/ASFTP/G/24) UPC : 4 973993 173586
Distribution
Distributed in 1 state:
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