IV START KIT Connector Defect May Cause Fluid Leaks
Cardinal Health's Presource Packs IV START KIT is being recalled due to a manufacturing defect in the connector that may cause fluid leaks and compromise intravenous fluid delivery.
The agency’s classification
FDA (Devices): 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 an FDA Class II recall affecting an IV access device where a manufacturing defect may compromise fluid path integrity. While no illnesses or injuries have been reported, this qualifies as a risk-of-harm medical device where the defect represents a functional failure in a critical infusion system.
Plain-English summary
Cardinal Health is recalling the Presource Packs IV START KIT (Catalog #01-5798B) because the ICU MicroClave Clear Connector contains a manufacturing defect. A gap between the connector's top and bottom housings may allow fluid to leak and compromise the integrity of the fluid delivery path.
The recalled product was distributed in Georgia and Pennsylvania. The affected lot number is 816643 with an expiration date of February 1, 2025.
IV connector leaks can interfere with proper delivery of medications and fluids to patients. No illnesses or injuries have been reported in connection with this defect.
Patients and healthcare providers should stop using affected kits immediately and contact Cardinal Health for replacement or proper disposal.
The recalled product
- Product
- Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 4,560
Distribution
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health 200, 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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