CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single recalled
Cardinal Health 200 is recalling Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single, 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-1871-2025
- 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. 8888160325; Umbilical Vessel Catheter 2.5 French single 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) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142
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. 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. 8888160648; Umbilical Vessel Catheter 5 French triple 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 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |