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Lower risk Medical device recall · FDA · Published May 2, 2025

Cardinal Health Umbilical Vessel Catheter Tray Recall: Packaging Defect Risks Neonatal

Cardinal Health recalls umbilical vessel catheter insertion trays with packaging defect that may compromise sterility, risking neonatal infections. Affected units include specific catalog numbers and lots.

🇺🇸 FDA recall #Z-1870-2025Medical deviceCardinal Health ›
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Contact the company

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337
✎ GovInfoNow plain-language explainer

Cardinal Health is recalling umbilical vessel catheter insertion trays due to a packaging defect that could compromise sterility. Using non-sterile products on neonates may lead to infections. Read more at govinfonow.com/recall/52348-cardinal-health-umbilical-vessel-catheter-tray-recall-packaging-defect-risks.

Source Summary by GovInfoNow · govinfonow.com/recall/52348-cardinal-health-umbilical-vessel-catheter-tray-recall-packaging-defect-risks · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1870-2025

Cite this page

“Cardinal Health Umbilical Vessel Catheter Tray Recall: Packaging Defect Risks Neonatal.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52348-cardinal-health-umbilical-vessel-catheter-tray-recall-packaging-defect-risks. Based on FDA recall #Z-1870-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1870-2025%22&limit=1).

Cardinal Health 200, LLC recalled one lot of Umbilical Vessel Catheter Insertion Tray with Catalog No. 8888160119 due to a packaging defect that may compromise sterility, the FDA said on May 2, 2025. Use of the non-sterile product could lead to infection in neonates.

How to tell if you have it

  • Brand: Cardinal Health
  • Product: Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
  • Catalog No.: 8888160119
  • Lot code: 2502400146

The hazard

The packaging defect may compromise the sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Context

GovInfoNow's records show Cardinal Health 200, LLC has 58 other recalls on record since 2017-06-27. Other recent recalls of similar products include Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets (2026-08-18), Presource Convenience Kits Recall (2026-08-10), and Presource Packs with Contaminated Wipes May Cause Skin Irritation (2026-07-29). Other recent recalls of similar products include Blood Culture Kits Recall (2026-06-12), Acute High Pressure Catheter Tray Recall (2025-10-17), and Convenience Kits Recall (2026-06-12).

How to tell if you have this one

Check for Catalog No. 8888160119 on the tray. The lot number 2502400146 is also associated with the affected units.

  • Brand
    Cardinal Health
  • Category
    Medical device
FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • 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, Canada, Chile, Colombia, Singapore, South Africa.
Recall numberProduct, codes & lotsQuantity
Z-1870-2025Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs; UDI-DI (ea) 10192253040289; UDI-DI (box) 50192253040287 Lot 2502400146370
Z-1871-2025Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen; UDI-DI (ea) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 24227001421710
Z-1872-2025Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen; 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 243130015558742
Z-1873-2025Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen; 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 243300009451378
Z-1874-2025Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen; UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 243520012410438
Z-1875-2025Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen; UDI-DI (ea) 10192253040371; UDI-DI (box) 50192253040379 Lots 2419800006 23355001492280
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for Catalog No. 8888160119 and lot number 2502400146 on the tray packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 39 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: 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.

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: May 2, 202512. FDA classified it Class II: May 29, 202523. Published in FDA’s Enforcement Report: Jun 4, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1870-2025 (May 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1870-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA