The Recall Desk
HighFDA (Devices)·Z-1875-2025·Announced 2025-06-04

Umbilical vessel catheter recalled due to packaging sterility defect

Cardinal Health is recalling 2,280 umbilical vessel catheters due to a packaging defect that may compromise product 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: This is a Class II recall of a sterile medical device used in vulnerable neonatal patients. No illnesses or injuries have been reported, making the hazard theoretical. However, the risk of serious infection from use of a non-sterile device in this critical patient population justifies a High severity classification.

Plain-English summary

Cardinal Health 200, LLC is recalling 2,280 Umbilical Vessel Catheters (catalog number 8888160648, 5 French triple lumen). The devices were distributed worldwide, including throughout the United States and internationally to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. The affected lot numbers are 2419800006 and 2335500149.

A packaging defect may compromise the sterility of the recalled devices. Umbilical vessel catheters are used for vascular access in neonates. According to the FDA, use of a non-sterile product could lead to infection in these patients.

The recalled product

Product
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Umbilical Catheter
Hazard
  • sterility-compromise
  • 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 (2)

  • UDI-DI (ea) 10192253040371
  • UDI-DI (box) 50192253040379 Lots 2419800006 2335500149

Distribution

Distributed nationwide across the United States.

Related recalls

Same category