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.
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: 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
- Affected units
- 31,300
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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