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Lower risk Medical device recall · FDA · Published April 28, 2021

Fresenius Citrasate and NaturaLyte Liquid Acid Concentrates: Risk of Freezing Due

Fresenius Medical Care recalls Citrasate and NaturaLyte Liquid Acid Concentrates due to potential freezing from refrigerated truck malfunctions. These products are used in hemodialysis. Affected lots have specific UDI numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2086-2021Medical deviceFresenius Medical Care ›
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Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer

Fresenius Medical Care recalls two liquid acid concentrates used in hemodialysis. They may freeze if refrigerated trucks malfunction, potentially causing safety issues during treatment. Read more at govinfonow.com/recall/62683-fresenius-citrasate-and-naturalyte-liquid-acid-concentrates-risk-of-freezing.

Source Summary by GovInfoNow · govinfonow.com/recall/62683-fresenius-citrasate-and-naturalyte-liquid-acid-concentrates-risk-of-freezing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2086-2021

Cite this page

“Fresenius Citrasate and NaturaLyte Liquid Acid Concentrates: Risk of Freezing Due.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62683-fresenius-citrasate-and-naturalyte-liquid-acid-concentrates-risk-of-freezing. Based on FDA recall #Z-2086-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2086-2021%22&limit=1).

The FDA announced on April 28, 2021, that Fresenius Medical Care Holdings, Inc. voluntarily recalled Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate due to exposure to freezing temperatures. The agency said the products were distributed only in Texas.

How to tell if you have it

  • Citrasate Liquid Acid Concentrate, UPC 00840861101535
  • NaturaLyte Liquid Acid Concentrate, UPC 00840861101696
  • NaturaLyte Liquid Acid Concentrate, UPC 00840861101740

The hazard

The concentrates were exposed to freezing temperatures because of refrigerated truck malfunctions. The FDA said this exposure could compromise the products intended for use in hemodialysis machines.

Context

GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has had 44 other recalls on record since April 14, 2014. Recent recalls include a May 12, 2026 notice for Bicarby Dialysate leaks and a May 11, 2026 alert for 5008X Blood Tubing Set port errors. Other recent recalls of similar products include Fresenius Medical Care Citrasate Liquid Acid Concentrate Recall (July 14, 2026), Fresenius NaturaLyte Liquid Acid Concentrate Recall (July 14, 2026), and Fresenius Medical Care GRANUFLO Dry Acid Concentrate Recall (July 14, 2026).

How to tell if you have this one

Check for lot numbers: (1)21BTAC004, (2)21AGAC026, (3)21BTAC008. These products were sold with specific UDI numbers listed in the recall notice.

  • Brand
    Fresenius Medical Care
  • Product
    Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component
  • Category
    Medical device
FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Distribution to: TX only
Recall numberProduct, codes & lotsQuantity
Z-2082-2021(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.; (1) Lot Number: B4MA27140 BAG GTIN CASE GTIN BIBAG 650 GRAMS 08-4078-BB 00840861101313 10840861101310 (2) Lot Number: B5MB24110 BAG GTIN CASE GTIN BIBAG 900 GRAMS 08-4080-BB 00840861101320 10840861101327(1) 20 cases (2) 30 cases
Z-2083-2021The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.; Lot Number: 20NR08163 UDI: (01)0084086110203710 cases
Z-2084-2021Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.; Lot Number/UDI: (1) 21ATGF013 (01)00884086110135 0FD3251-3B (2) 20SXGF010 (01)00840861101597 0FD3251-3B (3) 20SXGF013 (01)00840861101597(1) 40 cases (2) 3 cases (3) 4 cases
Z-2085-2021026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting; Lot Number: 20HR08054 UDI: (01)008408611011156 Cases
Z-2086-2021Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.; Lot Number/UDI: (1)21BTAC004 UDI: (01)00840861101535 (2)21AGAC026 UDI: (01)00840861101696 (3)21BTAC008 UDI: (01)00840861101740(1) 1 case (2) 4 cases (3) 5 cases
Z-2087-2021NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.; Lot Number: 21ATBC004 UDI: (01)00840861101955120 Bags
Z-2088-2021The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).; Lot Number: 20LR08111 UDI: (01)008408611008115 cases
Z-2089-2021The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.; Lot Number: 20SR08069 UDI: (01)00840861100811 20PR08237 UDI: (01)008408611008115 cases
Z-2090-2021050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system; Lot Number: B1ZH191, B1ZI09239 cases
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for lot numbers (1)21BTAC004, (2)21AGAC026, or (3)21BTAC008 on the product label.

Where it went and when

Where it was distributed

Distributed in Texas.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “US Distribution to: TX only” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Texas.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Apr 28, 202112. FDA classified it Class II: Jul 16, 202123. Published in FDA’s Enforcement Report: Jul 28, 202134. FDA terminated the recall: Aug 8, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Other Fresenius Medical Care recalls

Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,
April 6, 2026

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2086-2021 (April 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2086-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA