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U.S. Department of Health and Human Services

Class 2 Device Recall Umbilical Catheter Single Lumen 3.5FR

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 Class 2 Device Recall Umbilical Catheter Single Lumen 3.5FRsee related information
Date Initiated by FirmMay 02, 2025
Date PostedMay 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1872-2025
Recall Event ID 96783
510(K)NumberK130725 
Product Classification Catheter, umbilical artery - Product Code FOS
ProductCatalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Code Information 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
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact
847-887-5500
Manufacturer 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.
FDA Determined
Cause 2		Package design/selection
ActionThe firm started notifying customers on May 2, 2025 via Urgent Medical Device Product Recall letters. Customers were instructed to remove any devices currently in use. In addition, customers should review their inventory and segregate/quarantine all affected product. If product has been further distributed, the distributor should notify all downstream customers. Customers are asked to return an acknowledgement form whether they have affected product or not. Customers should contact the firm to arrange for return and credit or questions regarding suitable alternative products. For questions related to this recall, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
Quantity in Commerce58742
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FOS
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