Cardinal Health Umbilical Vessel Catheter recalled for sterility defect
Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall with a high-risk hazard (potential infection from non-sterile product in neonates). Although no illnesses have been reported, the risk of harm to vulnerable patients is significant, meeting the rubric criterion for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling Catalog No. 8888160333 Umbilical Vessel Catheters (3.5 French single lumen). A packaging defect may compromise the sterility of the product.
Use of a non-sterile product on a patient could lead to infection in neonates. The affected catheters were distributed nationwide throughout the United States, including all states, as well as to Brazil, Canada, Chile, Colombia, Singapore, and South Africa.
Affected lot numbers are: 2431300157, 2431300158, 2431300156, 2431300154, 2431300153, 2433300197, 2431300152, 2418100101, 2433300200, 2418300064, 2432300069, 2417000115, 2431800139, 2432200143, 2432600251, 2417000116, 2433300199, 2418100103, 2432300066, 2418300063, 2433300195, 2432600250, 2430300087, 2433300193, 2430300085, 2417000113, 2433300201, 2432200139, 2429900138, 2412300004, 2430300083, 2430300086, 2430300084, 2418100102, and 2431300155.
Hospitals and healthcare providers who have received affected units should quarantine them and contact Cardinal Health 200, LLC for instructions on handling or replacement.
The recalled product
- Product
- Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 58,742
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
Part of a larger recall action
This product is one of 6 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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