Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect
Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause 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 involving a high-risk scenario (potential infection in neonates from non-sterile product). The source explicitly states the potential harm (infection) but does not report any actual illnesses or injuries, placing it at the high end of Class II / High severity per the rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling Catalog No. 8888160325 Umbilical Vessel Catheter 2.5 French single lumen. The recall affects 1,710 units distributed nationwide across all U.S. states and to Brazil, Canada, Chile, Colombia, Singapore, and South Africa.
A packaging defect may compromise the sterility of the product. If a non-sterile catheter is used on a patient, it could lead to infection in neonates. Affected lot numbers are 2433100060, 2433100059, 2422700145, 2422700139, 2422700146, and 2422700142.
If you have received this product, do not use it. Contact Cardinal Health 200, LLC or the FDA for instructions on how to handle your inventory.
The recalled product
- Product
- Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 1,710
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
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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