The Recall Desk
HighFDA (Devices)·Z-1158-2023·Announced 2023-03-01

IV Access Device Kit Recalled Due to Manufacturing Defect in Connector

Cardinal Health is recalling Presource Packs IV START TRAY I kits due to a manufacturing defect in the ICU MicroClave Clear Connector that may cause fluid leaks and loss of fluid path integrity.

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: FDA Class II medical device with a confirmed manufacturing defect that poses a risk of fluid path compromise in an IV system. No hospitalizations or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling the Presource Packs IV START TRAY I (catalog number 01-5799A), an intravenous access device kit. The affected lot is 706265 with an expiration date of May 1, 2024.

The recall was initiated due to a manufacturing defect in the ICU MicroClave Clear Connector included in these kits. A gap between the connector's top and bottom housings may lead to fluid leaks and loss of fluid path integrity.

The affected products were distributed nationwide in Georgia and Pennsylvania. Healthcare facilities and users should discontinue use of affected units immediately and contact Cardinal Health for replacement or return instructions.

The recalled product

Product
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Intravenous Access Device
Hazard
  • manufacturing-defect
  • fluid-leak
  • loss-of-integrity

Distribution

Distributed nationwide across the United States.

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