Umbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters 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 recall involving a sterility defect on a high-risk medical device used in neonatal care. The hazard (infection in neonates from non-sterile products) represents a significant risk of harm, and the source text indicates no illnesses have yet been reported, placing this at the upper boundary of the High category.
Plain-English summary
Cardinal Health 200, LLC is recalling Catalog No. 8888160556 Umbilical Vessel Catheter 5 French dual lumen devices due to a packaging defect that may compromise sterility of the product. A total of 10,438 units have been distributed worldwide, including throughout the United States and in Brazil, Canada, Chile, Colombia, Singapore, and South Africa.
The affected lot numbers are 2424900133, 2424900134, 2424900135, 2435200126, 2435200127, 2435200129, 2435200123, and 2435200124 (UDI-DI per carton and unit level: 50192253040362 and 10192253040364, respectively). Use of a non-sterile product on patients could lead to infection in neonates.
If you have received or used any of these devices, contact Cardinal Health 200, LLC immediately for instructions on return or replacement. Do not use any affected lots.
The recalled product
- Product
- Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 10,438
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) 10192253040364
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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