PlainRecordsFDA · Medical device recall
Catalog No… and 5 more products
- Reason
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Status
- Ongoing
- 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…
- Enforcement report date
- June 4, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Cardinal Health 200, LLC
- Reason
- Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Distribution pattern
- 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.
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.”Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs, FDA enforcement report, 2025-06-04. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Catheter, Umbilical Artery
Distributed in (FDA's record): Alabama Alaska Arizona Arkansas California Colorado Connecticut Florida Georgia Hawaii Illinois Indiana Iowa Kansas Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri New Jersey New Mexico New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Dakota Tennessee Texas Utah Virginia Washington West Virginia Wisconsin and nationwide
6 products in this recall
Catalog No…
- Product
- Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
- Quantity
- 370
- Codes and lots
- UDI-DI (ea) 10192253040289; UDI-DI (box) 50192253040287 Lot 2502400146
- Recall started
- May 2, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheter, Umbilical Artery
- Root cause (FDA)
- Package design/selection
- What the company told customers
- 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Recall number
- Z-1870-2025
Catalog No…
- Product
- Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
- Quantity
- 1710
- Codes and lots
- UDI-DI (ea) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142
- Recall started
- May 2, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheter, Umbilical Artery
- Root cause (FDA)
- Package design/selection
- What the company told customers
- 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Recall number
- Z-1871-2025
Catalog No…
- Product
- Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
- Quantity
- 58742
- 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
- Recall started
- May 2, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheter, Umbilical Artery
- Root cause (FDA)
- Package design/selection
- What the company told customers
- 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Recall number
- Z-1872-2025
Catalog No…
- Product
- Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
- Quantity
- 51378
- 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
- Recall started
- May 2, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheter, Umbilical Artery
- Root cause (FDA)
- Package design/selection
- What the company told customers
- 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Recall number
- Z-1873-2025
Catalog No…
- Product
- Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
- Quantity
- 10438
- Codes and lots
- UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124
- Recall started
- May 2, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheter, Umbilical Artery
- Root cause (FDA)
- Package design/selection
- What the company told customers
- 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Recall number
- Z-1874-2025
Catalog No…
- Product
- Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
- Quantity
- 2280
- Codes and lots
- UDI-DI (ea) 10192253040371; UDI-DI (box) 50192253040379 Lots 2419800006 2335500149
- Recall started
- May 2, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheter, Umbilical Artery
- Root cause (FDA)
- Package design/selection
- What the company told customers
- 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Recall number
- Z-1875-2025
This recall among the others
- FDA's enforcement report came 33 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Cardinal Health 200: 19 other recalls or notices on this site in the three years before this one (from June 5, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1870-2025, Z-1871-2025, Z-1872-2025, Z-1873-2025, Z-1874-2025, Z-1875-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1870-2025, June 4, 2025. "Catalog No… and 5 more products." PlainRecords, https://plainrecords.com/recall/device/z-1870-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections