Umbilical Catheter Insertion Tray Recall Due to Packaging Defect Risk
Cardinal Health is recalling 370 units of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility, posing infection risk to neonates.
What this means for you
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 a risk-of-harm medical device recall affecting neonatal patients. The packaging defect may compromise product sterility, creating potential infection risk in a vulnerable population. No illnesses or injuries have been reported, placing this FDA Class II recall at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling the Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs (Catalog No. 8888160119) due to a packaging defect.
A packaging defect may compromise the sterility of the product. If non-sterile products are used on patients, they could lead to infections, particularly in neonates.
The recall affects 370 units distributed worldwide, including US nationwide distribution across all 50 states, plus Puerto Rico, and internationally to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. The affected lot is 2502400146.
Healthcare facilities and clinicians who received this product should stop using it immediately and contact Cardinal Health 200, LLC for instructions on returning or disposing of the affected trays.
The recalled product
- Product
- Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- packaging-defect
- sterility-compromise
- infection-risk
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
Distributed nationwide across the United States.
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