Umbilical Vessel Catheter 5 French Triple Lumen Recall
Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. 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 of a sterile medical device where the defect creates a risk of serious harm (neonatal infection) in a high-risk population. The source text does not report any confirmed illnesses or injuries, making it meet the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling the Umbilical Vessel Catheter 5 French triple lumen (Catalog No. 8888160648) due to a packaging defect that may compromise product sterility. Affected lots are 2419800006 and 2335500149, with approximately 2,280 units distributed.
The devices were distributed nationwide across the United States and internationally to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. Use of a non-sterile catheter on a patient could lead to infection in neonates.
If you have received this product, contact Cardinal Health 200, LLC for instructions on return or disposal. Healthcare providers should review their inventory and cease use of the affected lots immediately.
The recalled product
- Product
- Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 2,280
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) 10192253040371
- UDI-DI (box) 50192253040379 Lots 2419800006 2335500149
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
Same manufacturer · Cardinal Health 200, LLC
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCustomed Recalls Umbilical Vessel Catheter Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Umbilical Vessel Catheter Kits Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- HighCustomed Umbilical Vessel Catheter Kits Recalled for Sterilization Defects
FDA (Devices) · 2015-09-09
- HighCardinal Health Recalls Monoject Blunt Cannulas Due to Sterility Barrier Defect
FDA (Devices) · 2019-07-31
- HighCardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
FDA (Devices) · 2013-04-03
- HighCustomed Recalls Umbilical Vessel Catheter Kits Due to Sterilization Concerns
FDA (Devices) · 2016-04-20