CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French recalled
Cardinal Health 200 is recalling Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen, distributed nationwide in the US. The recall was initiated on 2 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1874-2025
- FDA event ID
- 96783
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 May 2025
- FDA classified
- 29 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 2 May 2025 | Recall initiated by company | |
| 29 May 2025 | Classified by FDA | +27 days |
| 4 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Is Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen recalled?
Yes. Cardinal Health 200 recalled Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen on 2 May 2025. The recall is Class II and its status is Ongoing. Recall number Z-1874-2025.
Why was it recalled?
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Which lots are affected?
UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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