Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Summary
The FDA issued a Class II for Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen by Cardinal Health 200, LLC. Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates..
Details
Source
Device Recall
External ID
Z-1872-2025
Action Date
2025-06-04
Status
Ongoing
Category
device
Product Description
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Lot/Code Info: UDI-DI (ea) 10192253040302; UDI-DI (box) 50192253040300 Lots 2431300157 2431300158 2431300156 2431300154 2431300153 2433300197 2431300152 2418100101 2433300200 2418300064 2432300069 2417000115 2431800139 2432200143 2432600251 2417000116 2433300199 2418100103 2432300066 2418300063 2433300195 2432600250 2430300087 2433300193 2430300085 2417000113 2433300201 2432200139 2429900138 2412300004 2430300083 2430300086 2430300084 2418100102 2431300155
Quantity Affected: 58742
Reason for Recall
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-02
Company
Waukegan, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1872-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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