Class II U.S. Food and Drug Administration

Fresenius Medical Care Holdings, Inc. Delflex, Dextrose Peritoneal Dialysis Solution recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags

Recall published 6 months ago

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

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
D-0513-2026
Published
May 13, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Fresenius Medical Care Holdings, Inc.
Product type
Prescription & OTC drugs
Units affected
43,225 bags
Distribution
Nationwide
Made in
United States
Lot / code info
Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013

Products covered by this recall

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

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

  • 25CU02002
  • 25CU02011
  • 25CU02012
  • 25CU02013 — 43
  • 225 bags

Model or item number

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

  • 054-20222
  • 92

Package size

Match the net weight or the piece count on the front of the pack.

  • 2 L
  • 5 PK

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

What to do about Sterility

Fresenius Medical Care Holdings, Inc. — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

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 — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fresenius Medical Care Holdings, Inc. prescription & otc… recalled?

Lack of Assurance of Sterility: Potential leaks from perforations in bags. Lack of Assurance of Sterility: Potential leaks from perforations in bags.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 25CU02002, 25CU02011, 25CU02012; model number 054-20222, 92. 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 affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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