Fresenius Medical Care recalls NATURALYTE Liquid Acid 3.0K 3.0Ca bottles with unqualified
Fresenius Medical Care recalls NATURALYTE Liquid Acid 3.0K 3.0Ca for bottles with caps labeled 'Sealed for your Protection' that aren't qualified for use in hemodialysis. This affects patients with kidney failure needing dialysis.
Recall notice
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Contact the company
What happened, in plain English
Fresenius Medical Care is recalling NATURALYTE Liquid Acid 3.0K 3.0Ca bottles that have caps labeled 'Sealed for your Protection' but aren't qualified for hemodialysis use. This could pose a risk to patients with kidney failure who require dialysis treatment. Read more at govinfonow.com/recall/60573-fresenius-medical-care-recalls-naturalyte-liquid-acid-3-0k-3.
Source Summary by GovInfoNow · govinfonow.com/recall/60573-fresenius-medical-care-recalls-naturalyte-liquid-acid-3-0k-3 · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1371-2022
Cite this page
“Fresenius Medical Care recalls NATURALYTE Liquid Acid 3.0K 3.0Ca bottles with unqualified.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60573-fresenius-medical-care-recalls-naturalyte-liquid-acid-3-0k-3. Based on FDA recall #Z-1371-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1371-2022%22&limit=1).
Why it’s dangerous
The bottle caps labeled 'Sealed for your Protection' are not qualified for use in hemodialysis. This could lead to improper sealing or leakage during treatment, potentially causing harm to patients with kidney failure.
Who’s affected
Patients undergoing hemodialysis for acute or chronic kidney failure are most at risk. The product is intended for use in dialysis treatments but the caps may not be safe.
How to tell if you have this one
Check for bottles labeled 'Sealed for your Protection' on the foil. The product has part number 08-3301-2 and lot number 22CTAC102, expiring March 31, 2024.
- Brand
Fresen:ius Medical Care- Category
Medical device
All 2 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
Ongoing- Distribution
Natiowide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1370-2022 | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0; UDI-DI: (01) 000840861101696 (17) 240331 (10) 22CTAC106 Lot Number: 22CTAC106 Exp Date: 2024-03-31 | 656 cases |
| Z-1371-2022 | NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2; UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31 | 163 cases |
What to do — step by step
Check Bottle Caps
Look for caps labeled 'Sealed for your Protection' on the foil. If present, the bottle may be recalled.
How this recall unfolded
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1371-2022 (May 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1371-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.