Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
FDA device recall Z-1870-2025 · posted 2025-05-29 · Open, Classified
Recall details
- Recalling firm
- Cardinal Health 200, LLC
- 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.
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Open, Classified
- Product code
- FOS
- Quantity affected
- 370
- Distribution
- 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
- Date initiated
- 2025-05-02
- Date posted
- 2025-05-29
- Location
- Waukegan, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY (K951737) | Sherwood Medical Co. | 1995-09-28 |