CLASS I ONGOING Device recall · Reported 11 Sep 2024 · FDA Enforcement Report
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing recalled
Fresenius Kabi USA is recalling LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty, distributed in Colorado, Idaho, New Jersey, Utah. The recall was initiated on 1 Aug 2024 and the FDA has classified it as Class I.
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-2721-2024
- FDA event ID
- 95113
- Recalling firm
- Fresenius Kabi USA, North Andover, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 1 Aug 2024
- FDA classified
- 4 Sep 2024
- Reported
- 11 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 1 Aug 2024 | Recall initiated by company | |
| 4 Sep 2024 | Classified by FDA | +34 days |
| 11 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
Where it was distributed
US Distribution to states of: CO, ID, NJ, UT.
Questions about this recall
Why was it recalled?
A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
Which lots are affected?
Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.
Where was it sold?
US Distribution to states of: CO, ID, NJ, UT.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
More recalls from Fresenius Kabi USA
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|---|---|---|---|---|---|
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| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
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Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |