CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple recalled
Cardinal Health 200 is recalling Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple, 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-1875-2025
- 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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple 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
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) 10192253040371; UDI-DI (box) 50192253040379 Lots 2419800006 2335500149
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 96783This product is part of a recall event; the main page for the event is Catalog No. 8888160119; Umbilical Vessel Catheter Insertion recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Catalog No. 8888160119; Umbilical Vessel Catheter Insertion recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single recalled | Cardinal Health 200 | Sterility | Nationwide | |
| CLASS II | Catalog No. 8888160556; Umbilical Vessel Catheter 5 French recalled | Cardinal Health 200 | Sterility | Nationwide |
More recalls from Cardinal Health 200
All 290| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs containing Medtronic Microstream Components recalled | Cardinal Health 200 | Device Malfunction | IL |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
| Device | CLASS II | Presource Packs Containing Stryker StrykeFlow PS recalled | Cardinal Health 200 | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |