CLASS II ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report

Citric Complete - Dry Citric Acid Concentrate recalled

Nipro Renal Soultions USA is recalling Citric Complete - Dry Citric Acid Concentrate, distributed in 10 states. The recall was initiated on 22 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.

Quantity recalled2,810 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-0820-2025
FDA event ID: 95878
Recalling firm: Nipro Renal Soultions USA, Lewisberry, PA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Nov 2024
FDA classified: 8 Jan 2025
Reported: 15 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

22 Nov 2024	Recall initiated by company
8 Jan 2025	Classified by FDA	+47 days
15 Jan 2025	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

The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

Product as listed by the FDA

Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

Where it was distributed

US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.

Arizona Florida Georgia Illinois Michigan North Carolina New Jersey Ohio Tennessee Texas

Questions about this recall

Why was it recalled?

The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

Which lots are affected?

Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.

Where was it sold?

US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.

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.

More recalls from Nipro Renal Soultions USA

All 6

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS II	MedicaLyte Bicarbonate Powder recalled by Nipro Renal Soultions USA	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS II	Citric Complete Liquid Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS II	MedicaLyte Liquid Bicarbonate Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
21 May 2025Device	CLASS I	MedicaLyte Liquid Bicarbonate Concentrate recalled	Nipro Renal Soultions USA	Foreign Material	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide