Recall Z-1871-2025 ยท FOS Catheter, Umbilical Artery
Cardinal Health 200, LLC
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
| Date | May 29, 2025 (initiated May 2, 2025) |
| Status | Open, Classified |
| Reason | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| Root cause | Package design/selection |
| 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 |
| Quantity | 1710 |
| 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, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Afr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130725 | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. Covidien Lp, Formerly Registered AS Kendall, Apr 17, 2013 |