The Recall Desk
HighFDA (Devices)·Z-1157-2023·Announced 2023-03-01

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.

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 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
Category
Medical Device — IV Access / Infusion Systems
Hazard
  • fluid-leak
  • connector-defect

Distribution

Distributed nationwide across the United States.

Related recalls

Same category