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U.S. Department of Health and Human Services

Class 2 Device Recall Umbilical Catheter Single Lumen 5FR

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 Class 2 Device Recall Umbilical Catheter Single Lumen 5FRsee related information
Date Initiated by FirmMay 02, 2025
Date PostedMay 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1873-2025
Recall Event ID 96783
510(K)NumberK130725 
Product Classification Catheter, umbilical artery - Product Code FOS
ProductCatalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Code Information UDI-DI (ea) 10192253040319; UDI-DI (box) 50192253040317 Lots 2427700158 2425600066 2433000005 2427700160 2425600067 2425600070 2415100113 2425600071 2427700159 2415100110 2412100093 2433000095 2425600069 2425600077 2415100116 2425600063 2425600074 2415100115 2415100114 2412100096 2425600072 2425600075 2404400061 2425600064 2415100106 2425600076 2415100107 2415100112 2425600073 2425600065 2404400062 2404400065 2415100093 2415100109 2415100111 2433000094
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 Commerce51378
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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