FDAClass IIJune 4, 2025

Catalog No. 8888160119 recall: Sterility Concern

Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs

Why was Catalog No. 8888160119 recalled?

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI (ea) 10192253040289; UDI-DI (box) 50192253040287 Lot 2502400146

Product
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Recalling firm
Cardinal Health 200, LLC
Quantity
370
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.
Recall date
June 4, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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