Z-1874-2025Class II

Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

Name: Z-1874-2025 Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Creator: Cardinal Health 200, LLC
Published: 2025-05-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-05-02 / Open, Classified / root cause: packaging

FDA source

Cardinal Health 200, LLC began a recall of Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen on 2025-05-02. FDA classified it as Class II and gives the reason as "Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1874-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-02
Posted: 2025-05-29
Recalling firm: Medtronic, Inc.
Product: Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Product code: FOS Catheter, Umbilical Artery
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.
Root cause tag: packaging
FDA 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 related to this recall, please contact the market action team at: [email protected] or call 800-292-9332.
Quantity in commerce: 10438
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 Africa.
Product codes and lots: UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1874-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1870-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-29
Z-1871-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-29
Z-1872-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-29
Z-1873-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-29
Z-1874-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-29
Z-1875-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-29

Product code FOS

K941814Class IIArgyle Dual Lumen Umbilical Vessel CatheterSherwood Medical Co. / cleared 1994-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)