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
- Affected units
- 36
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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