Z-1871-2025Class II
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Medtronic, Inc. / initiated 2025-05-02 / Open, Classified / root cause: packaging
Cardinal Health 200, LLC began a recall of Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 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-1871-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- Product
- Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 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
- 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 Africa.
- Product codes and lots
- UDI-DI (ea) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142
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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