Umbilical vessel catheters recalled due to packaging defect compromising sterility
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters used on neonates could cause infection.
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 with no reported illnesses or injuries. The hazard is a sterility defect on a neonatal medical device where theoretical infection risk exists but no actual cases have been reported, meeting the rubric criterion for High (Score 3): 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cardinal Health 200, LLC is recalling 58,742 units of the Umbilical Vessel Catheter 3.5 French single lumen (Catalog No. 8888160333) due to a packaging defect.
The packaging defect may compromise the sterility of the catheter. If a non-sterile catheter is used on a patient, it could lead to infection in neonates.
The affected product has been distributed worldwide. In the United States, distribution includes all 50 states, plus Puerto Rico. Internationally, the product has been distributed to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. The specific lot numbers affected are listed on the FDA recall notice.
If you have received this product, contact Cardinal Health 200, LLC immediately. Do not use the affected catheters. Healthcare facilities should quarantine and return unused stock.
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.
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