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U.S. Department of Health and Human Services

Class 2 Device Recall Umbilical Catheter Dual Lumen 5FR

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 Class 2 Device Recall Umbilical Catheter Dual Lumen 5FRsee related information
Date Initiated by FirmMay 02, 2025
Date PostedMay 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1874-2025
Recall Event ID 96783
510(K)NumberK941814 
Product Classification Catheter, umbilical artery - Product Code FOS
ProductCatalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Code Information UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124
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 Commerce10438
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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