Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
FDA Recall Z-1872-2025 · Posted 2025-05-29
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Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeFOS
Date Initiated2025-05-02
Product Quantity58742
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.
Firm Action
The 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:
[email protected] or call 800-292-9332.
Root Cause
Package design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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