Recall Z-1875-2025— Cardinal Health 200, LLC

Name: FDA recall Z-1875-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-02

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2025-05-02. It names one FDA 510(k) clearance: K951738. Product: Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen. Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-05-02
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K951738 — ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETERSherwood Medical Co.·cleared 1995-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.