CLASS II ONGOING Device recall · Reported 6 Aug 2025 · 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, Dual Y-Site, distributed nationwide in the US. The recall was initiated on 24 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: SET-0032-25. UDI-DI: 00811505030214. Lot Codes: FA24J03137, FA24J03145, FA24J07013, FA24J07021, FA24J14019, FA24J14027, FA24J21246, FA24J21253, FA24J24141, FA24J24166, FA24J28027, FA24J28035, FA24K01154, FA24K01162, FA24K11039, FA24K11047, FA24K11161, FA24K18034, FA24K18042, FA24K18059, FA24K25229, FA24L03133, FA24L09221, FA24L10203, FA24L11201, FA24L11219, FA24L16010, FA24L16028, FA24L16036, FA24L18180, FA24L19139, FA24L19147.

Quantity recalled348,150 units

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-2235-2025
FDA event ID: 97165
Recalling firm: Fresenius Kabi USA, North Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2025
FDA classified: 31 Jul 2025
Reported: 6 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Infusion Pumps

Timeline

24 Jun 2025	Recall initiated by company
31 Jul 2025	Classified by FDA	+37 days
6 Aug 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

Potential for external cassette leaks

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

Where it was distributed

US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

Nationwide California Colorado Delaware Florida Georgia Idaho Illinois Massachusetts Maryland Michigan Minnesota Mississippi New Jersey Nevada Oklahoma Oregon South Carolina Texas Virginia Washington

Questions about this recall

Why was it recalled?

Potential for external cassette leaks

Which lots are affected?

Product Code: SET-0032-25. UDI-DI: 00811505030214. Lot Codes: FA24J03137, FA24J03145, FA24J07013, FA24J07021, FA24J14019, FA24J14027, FA24J21246, FA24J21253, FA24J24141, FA24J24166, FA24J28027, FA24J28035, FA24K01154, FA24K01162, FA24K11039, FA24K11047, FA24K11161, FA24K18034, FA24K18042, FA24K18059, FA24K25229, FA24L03133, FA24L09221, FA24L10203, FA24L11201, FA24L11219, FA24L16010, FA24L16028, FA24L16036, FA24L18180, FA24L19139, FA24L19147.

Where was it sold?

US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

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

3 other products · FDA event 97165

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025	CLASS II	LVP Primary Administration Set, Dual-Inlet, Low-Sorbing recalled	Fresenius Kabi USA	Packaging Defects	Nationwide
6 Aug 2025	CLASS II	LVP Primary Administration Set, Single Outlet Low Sorbing (Qty recalled	Fresenius Kabi USA	Packaging Defects	Nationwide
6 Aug 2025	CLASS II	LVP Blood Products Administration Set Dual-Inlet recalled	Fresenius Kabi USA	Packaging Defects	Nationwide

More recalls from Fresenius Kabi USA

All 94

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS I	Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne	Fresenius Kabi USA	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS I	Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate	Fresenius Kabi USA	Packaging Defects	Nationwide
29 Jul 2026Drug	CLASS II	Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine	Fresenius Kabi USA	Particulate Matter	Nationwide

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19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide