The Recall Desk
HighFDA (Devices)·Z-1159-2023·Announced 2023-03-01

IV Start Kit Recalled Due to Connector Manufacturing Defect

Cardinal Health Presource Packs IV start kits with ICU MicroClave Clear Connectors are being recalled due to a manufacturing defect 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 recall involving a manufacturing defect that poses potential risk of fluid leakage and loss of fluid path integrity in intravenous access equipment. No reported illnesses or injuries limits the score to High per the rubric, which caps theoretical risks without confirmed harm at score 3.

Plain-English summary

Cardinal Health 200, LLC is recalling Presource Packs IV START KIT (Catalog #01A4553E) due to a manufacturing defect in the ICU MicroClave Clear Connector. The connector contains a gap between the top and bottom housings that may lead to fluid leaks and loss of fluid path integrity.

The affected kits were distributed nationwide to healthcare facilities in Georgia and Pennsylvania. Lot number 818636, with expiration date March 1, 2024, is involved in this recall.

Healthcare providers and consumers using these kits should discontinue use and contact Cardinal Health 200, LLC regarding replacement or alternative products. No illnesses or injuries have been reported to date in connection with this manufacturing defect.

The recalled product

Product
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — IV Access
Hazard
  • manufacturing-defect
  • fluid-leakage
  • connector-failure

Distribution

Distributed nationwide across the United States.

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