Cardinal Health Umbilical Vessel Catheter recalled for sterility defect
Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to 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: This is an FDA Class II medical device recall with a high-risk hazard (potential infection from non-sterile product in neonates). Although no illnesses have been reported, the risk of harm to vulnerable patients is significant, meeting the rubric criterion for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling Catalog No. 8888160333 Umbilical Vessel Catheters (3.5 French single lumen). A packaging defect may compromise the sterility of the product.
Use of a non-sterile product on a patient could lead to infection in neonates. The affected catheters were distributed nationwide throughout the United States, including all states, as well as to Brazil, Canada, Chile, Colombia, Singapore, and South Africa.
Affected lot numbers are: 2431300157, 2431300158, 2431300156, 2431300154, 2431300153, 2433300197, 2431300152, 2418100101, 2433300200, 2418300064, 2432300069, 2417000115, 2431800139, 2432200143, 2432600251, 2417000116, 2433300199, 2418100103, 2432300066, 2418300063, 2433300195, 2432600250, 2430300087, 2433300193, 2430300085, 2417000113, 2433300201, 2432200139, 2429900138, 2412300004, 2430300083, 2430300086, 2430300084, 2418100102, and 2431300155.
Hospitals and healthcare providers who have received affected units should quarantine them and contact Cardinal Health 200, LLC for instructions on handling or replacement.
The recalled product
- Product
- Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- sterility-defect
- infection-risk
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) 10192253040302
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22