Food, drugs, devices › Cardinal Health 200, LLC
Device recall: Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Cardinal Health 200, LLC (Waukegan, IL) initiated this device recall on 2 May 2025; FDA lists 6 product records under event 96783, classified Class II.
FDA defines Class II as 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Cardinal Health 200, LLC has 59 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cardinal Health 200, LLC, Waukegan, IL.
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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1870-2025 | Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs | 370 | Class II | Ongoing | 4 Jun 2025 |
| Z-1871-2025 | Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen | 1710 | Class II | Ongoing | 4 Jun 2025 |
| Z-1872-2025 | Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen | 58742 | Class II | Ongoing | 4 Jun 2025 |
| Z-1873-2025 | Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen | 51378 | Class II | Ongoing | 4 Jun 2025 |
| Z-1874-2025 | Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen | 10438 | Class II | Ongoing | 4 Jun 2025 |
| Z-1875-2025 | Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen | 2280 | Class II | Ongoing | 4 Jun 2025 |
Context
Other enforcement events for Cardinal Health 200, LLC
All 59 events for Cardinal Health 200, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.