Cardinal Health 200, LLC recalls Catalog No. 8888160333

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen

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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.

• FDA enforcement recordOfficial FDA database entry for Z-1872-2025
• FDA 510(k) clearance · K130725The device's official FDA premarket clearance record
• FDA device classification · FOSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Cardinal Health 200, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.