Umbilical Vessel Catheters Recalled Due to Sterility Packaging Defect
Cardinal Health recalls 1,710 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile devices 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: This is an FDA Class II recall involving a serious risk—potential infection from sterile compromise in neonatal devices. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario that meets the rubric criterion for High severity.
Plain-English summary
Cardinal Health 200, LLC is recalling Umbilical Vessel Catheters (Catalog No. 8888160325, 2.5 French single lumen) due to a packaging defect that may compromise the sterility of the product. A total of 1,710 affected units have been distributed worldwide, including throughout the United States and internationally to Brazil, Canada, Chile, Colombia, Singapore, and South Africa.
Use of a non-sterile device on a patient could result in infection, which is a serious concern in neonatal care. The specific lot numbers affected are 2433100060, 2433100059, 2422700145, 2422700139, 2422700146, and 2422700142.
Healthcare providers should verify whether they have received units from the affected lots. Those who have should discontinue use and contact Cardinal Health 200, LLC for replacement units or additional information about this recall.
The recalled product
- Product
- Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 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) 10192253040296
Distribution
Distributed nationwide across the United States.
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