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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Cardinal Health Umbilical Vessel Catheters Recalled for Loss of Sterility

Agency Publication Date: May 29, 2025
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Summary

Cardinal Health 200, LLC has recalled 124,918 Umbilical Vessel Catheter (UVC) products, including single, dual, and triple lumen catheters as well as insertion trays. The recall was issued because a packaging defect may compromise the sterile seal of the product. The catheters are typically used in neonatal patients, and if a non-sterile device is used, it could lead to serious or life-threatening infections. No injuries or incidents have been reported to date.

Risk

A packaging defect can allow the sterile environment inside the catheter pouch to be breached. Use of a non-sterile medical device in newborns can introduce pathogens directly into the bloodstream, posing a high risk of infection and serious medical complications.

What You Should Do

  1. This recall affects Cardinal Health Umbilical Vessel Catheters and Insertion Trays, including Catalog Numbers 8888160119, 8888160325, 8888160333, 8888160341, 8888160556, and 8888160648.
  2. Identify your products by checking the catalog number, lot number, and Unique Device Identifier (UDI) located on the device label or box. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Model / REF:
8888160119
Lot Numbers:
2502400146
UDI:
10192253040289
50192253040287
Product: Umbilical Vessel Catheter 2.5 French single lumen
Model / REF:
8888160325
Lot Numbers:
2433100060
2433100059
2422700145
2422700139
2422700146
2422700142
UDI:
10192253040296
50192253040294
Product: Umbilical Vessel Catheter 3.5 French single lumen
Model / REF:
8888160333
Lot Numbers:
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
UDI:
10192253040302
50192253040300
Product: Umbilical Vessel Catheter 5 French single lumen
Model / REF:
8888160341
Lot Numbers:
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
UDI:
10192253040319
50192253040317
Product: Umbilical Vessel Catheter 5 French dual lumen
Model / REF:
8888160556
Lot Numbers:
2424900133
2424900134
2424900135
2435200126
2435200127
2435200129
2435200123
2435200124
UDI:
10192253040364
50192253040362
Product: Umbilical Vessel Catheter 5 French triple lumen
Model / REF:
8888160648
Lot Numbers:
2419800006
2335500149
UDI:
10192253040371
50192253040379

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96783
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Cardinal Health 200, LLC; Medical distributors; Hospitals
Manufactured In: United States
Units Affected: 6 products (370; 1710; 58742; 51378; 10438; 2280)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.