Umbilical Vessel Catheters Recalled for Sterility-Compromising Packaging Defect
Cardinal Health is recalling 51,378 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in newborns.
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 of neonatal medical device with packaging defect that may compromise sterility and risk infection in vulnerable newborns. No illnesses or injuries reported, placing this in the High category per FDA severity rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 51,378 units of Model 8888160341 Umbilical Vessel Catheters (5 French, single lumen) due to a packaging defect that may compromise product sterility.
The affected catheters were distributed worldwide, including throughout the United States and to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. If a non-sterile catheter is used on a patient, it could lead to infection in neonates (newborns).
Healthcare facilities that received these catheters should check their inventory against the affected lot numbers and follow Cardinal Health's instructions for handling the affected products. Patients and caregivers should contact their healthcare provider if they have questions about whether a catheter used in treatment came from the recalled lots.
The recalled product
- Product
- Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- packaging-defect
- 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 (1)
- UDI-DI (ea) 10192253040319
Distribution
Distributed nationwide across the United States.
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