Agency classClass IIOur severity:High FDA (Food)·F-1685-2022·Announced 2022-09-07

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.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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…
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.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Clinical Innovations, LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Clinical Innovations, LLC

See all →

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Clinical Innovations Sweetums Sucrose Solution Vials Recalled for Contamination
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Same hazard · contamination risk