Z-1872-2025Class II
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Medtronic, Inc. / initiated 2025-05-02 / Open, Classified / root cause: packaging
Cardinal Health 200, LLC began a recall of Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 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-1872-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- Product
- Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 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
- 58742
- 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) 10192253040302; UDI-DI (box) 50192253040300 Lots 2431300157 2431300158 2431300156 2431300154 2431300153 2433300197 2431300152 2418100101 2433300200 2418300064 2432300069 2417000115 2431800139 2432200143 2432600251 2417000116 2433300199 2418100103 2432300066 2418300063 2433300195 2432600250 2430300087 2433300193 2430300085 2417000113 2433300201 2432200139 2429900138 2412300004 2430300083 2430300086 2430300084 2418100102 2431300155
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1870-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1871-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1872-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1873-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1874-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1875-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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