Umbilical Vessel Catheter 5 French Triple Lumen Recall
Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters 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 recall of a sterile medical device where the defect creates a risk of serious harm (neonatal infection) in a high-risk population. The source text does not report any confirmed illnesses or injuries, making it meet the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling the Umbilical Vessel Catheter 5 French triple lumen (Catalog No. 8888160648) due to a packaging defect that may compromise product sterility. Affected lots are 2419800006 and 2335500149, with approximately 2,280 units distributed.
The devices were distributed nationwide across the United States and internationally to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. Use of a non-sterile catheter on a patient could lead to infection in neonates.
If you have received this product, contact Cardinal Health 200, LLC for instructions on return or disposal. Healthcare providers should review their inventory and cease use of the affected lots immediately.
The recalled product
- Product
- Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
- Manufacturer
- Cardinal Health 200, LLC
- 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.
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