Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall
Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.
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: FDA Class II recall where the hazard is infection in high-risk neonatal patients if sterility is compromised. Although no illnesses have been reported, the potential for serious harm in vulnerable patients and the nature of the defect warrant a High severity classification.
Plain-English summary
Cardinal Health 200, LLC is recalling Catalog No. 8888160119 Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs due to a packaging defect that may compromise the sterility of the product. The affected lot is 2502400146, with 370 units distributed.
The trays were distributed worldwide, including to the US and internationally to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. Use of a non-sterile product on neonatal patients could lead to infection.
Healthcare providers and patients who have received affected trays should contact their healthcare provider or Cardinal Health with questions or to report any adverse events.
The recalled product
- Product
- Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 370
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) 10192253040289
- UDI-DI (box) 50192253040287 Lot 2502400146
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.
See all 6 products in this recall →Related recalls
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