Recall Z-1159-2023— Cardinal Health 200, LLC
Class II · Ongoing
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2022-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E. Reason: Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity.
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-18
- Firm location
- Waukegan, IL, United States
Product description
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Reason for recall
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
Data sourced from openFDA. This site is unofficial and independent of the FDA.