Sucrose solution vials recalled nationwide for contamination and leaking
Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to reports of leaking containers and contamination with black liquid and particulates. The product is used in hospital settings including neonatal intensive care units.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a medical device used in neonatal intensive care. Although no illnesses or injuries have been reported, the contamination (black liquid and particulates) in vials administered to vulnerable neonates represents a significant risk of harm.
Plain-English summary
Clinical Innovations, LLC is recalling Sweetums 24% sucrose solution vials following reports of leaking containers and contamination with black liquid and particulates. The affected product consists of 1mL or 2mL vials containing 24% sucrose in purified water with preservative, used exclusively in hospital settings including neonatal intensive care units.
The recall affects approximately 10,922 boxes (each containing 250 vials) with lot code VPSU15032250, distributed nationwide to all 48 states, Washington DC, and Puerto Rico, as well as to Australia and the United Arab Emirates.
Healthcare facilities in possession of this product should discontinue use immediately and contact Clinical Innovations, LLC for information regarding product replacement or refund. Do not use any vials that display signs of leaking or black discoloration.
This is a Food and Drug Administration Class II recall.
The recalled product
- Product
- Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting
- Manufacturer
- Clinical Innovations, LLC
- Category
- Medical Device — Neonatal Care
- Hazard
- contamination-risk
- foreign-material
- leaking
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)
- VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023
Distribution
Distributed nationwide across the United States.
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