Cardinal Health Umbilical Catheters Recalled for Packaging Sterility Defect
Cardinal Health is recalling 10,438 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.
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 recall with no reported illnesses or injuries. However, the risk of infection in neonates from non-sterile medical devices constitutes a risk-of-harm scenario warranting High severity per the rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling Catalog No. 8888160556 Umbilical Vessel Catheters (5 French dual lumen) due to a packaging defect that may compromise product sterility. A total of 10,438 units have been distributed.
The packaging defect may allow the product to become non-sterile. Use of a non-sterile catheter on a patient could lead to infection in neonates.
The affected catheters were distributed worldwide, including to all US states and internationally to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. Specific lot numbers affected are: 2424900133, 2424900134, 2424900135, 2435200126, 2435200127, 2435200129, 2435200123, and 2435200124.
Healthcare providers should immediately discontinue use of affected inventory and contact Cardinal Health or the FDA for return and replacement instructions.
The recalled product
- Product
- Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- sterility-compromise
- infection-risk
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI (ea) 10192253040364
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03