Class II U.S. Food and Drug Administration

Fresenius Medical Care Holdings, Inc. Bicarby" Dialysate recall: Given the increased number of leaks reported by users

Recall published 4 months ago

Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

The hazard: Fall or tip-over hazard

A fall or tip-over risk prompted this notice. With furniture, the typical victim is a toddler who used a drawer as a step.

What the notice says: Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

Why it matters: The product can tip, collapse or give way under normal use. Furniture tip-overs in particular kill and injure young children, usually when a child climbs on an open drawer.

Symptoms and when to call a doctor

After a fall or a tip-over involving a child, watch for a headache that gets worse, repeated vomiting, drowsiness that is hard to rouse, confusion, unequal pupils, clear fluid from the nose or ear, or a seizure, and call 911 if any of these appear. Any fall onto the head in a baby under one, or any loss of consciousness at any age, needs to be assessed the same day.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2321-2026
Published
June 17, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Fresenius Medical Care Holdings, Inc.
Product type
Medical devices
Units affected
1,756,108 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model Number: RFP-400-G; UDI-DI: 00840861102839; 2. Model Number: RFP-401-G; UDI-DI: 00840861102853; 3. Model Number: RFP-402-G; UDI-DI: 00840861102822; 4. Model Number: RFP-404-G; UDI-DI: 00840861102914; 5. Model Number: RFP-407-G; UDI-DI: 00840861102846: 6. Model Number: RFP-456-G; UDI-DI: 00840861102945; All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026
UPC codes
00840861102839, 00840861102853, 00840861102822, 00840861102914, 00840861102846, 00840861102945

Products covered by this recall

Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00840861102839
  • 00840861102853
  • 00840861102822
  • 00840861102914
  • 00840861102846
  • 00840861102945

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2025
  • 20

Model or item number

On the rating label, the box or the instruction sheet.

  • RFP-400-G
  • RFP-401-G
  • RFP-402-G
  • RFP-404-G
  • RFP-407
  • RFP-407-G
  • RFP-456-G

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fall

Fresenius Medical Care Holdings, Inc. — A fall or tip-over risk prompted this notice. With furniture, the typical victim is a toddler who used a drawer as a step.

  1. Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.
  2. Keep TVs, toys and anything else tempting off the top of tall furniture, because that is what draws a child to climb.
  3. Inspect similar units from the same range, since a weak joint or fastener usually affects a whole production run.
  4. Follow the remedy on this page; many of these recalls supply a free anchoring kit as well as a refund.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.

Company contact: Fresenius Medical Care Holdings, Inc. — 920 Winter St Bld 920, Waltham, MA, 02451-1521

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fresenius Medical Care Holdings, Inc. medical devices recalled?

Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor. Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00840861102839, 00840861102853, 00840861102822; lot code 2025, 20; model number RFP-400-G, RFP-401-G, RFP-402-G. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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