510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1873-2025Class II

Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

Medtronic, Inc. / initiated 2025-05-02 / Open, Classified / root cause: packaging
FDA source (opens on fda.gov)

Cardinal Health 200, LLC began a recall of Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen on . 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 , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1873-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic, Inc.
Product
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single 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
51378
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) 10192253040319; UDI-DI (box) 50192253040317 Lots 2427700158 2425600066 2433000005 2427700160 2425600067 2425600070 2415100113 2425600071 2427700159 2415100110 2412100093 2433000095 2425600069 2425600077 2415100116 2425600063 2425600074 2415100115 2415100114 2412100096 2425600072 2425600075 2404400061 2425600064 2415100106 2425600076 2415100107 2415100112 2425600073 2425600065 2404400062 2404400065 2415100093 2415100109 2415100111 2433000094

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1873-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1870-2025Class IIOngoingVoluntary: Firm initiated
Z-1871-2025Class IIOngoingVoluntary: Firm initiated
Z-1872-2025Class IIOngoingVoluntary: Firm initiated
Z-1873-2025Class IIOngoingVoluntary: Firm initiated
Z-1874-2025Class IIOngoingVoluntary: Firm initiated
Z-1875-2025Class IIOngoingVoluntary: Firm initiated