Recall Weekly
Moderate riskFDA DrugClass II

DELFLEX peritoneal dialysis solution recalled for sterility concerns

Fresenius Medical Care is recalling certain lots of DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose because the sterility of the product cannot be assured. Complaints report potential leaks from small perforations in the print area of the primary bag in the affected lots. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Talk to your pharmacist or prescriber before stopping this solution.
  2. Check whether the bag lot number is 25HGPD037 (expires 12/31/2026) or 26CGPD074 (expires 9/30/2027). Lots are listed on the bag.
  3. The notice does not say how to get a replacement or refund. Contact NxStage Medical or your dialysis provider for next steps.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,500 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT. NO. 054-25321. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-206-94
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
1,065 cases (5 bags per case)
Illnesses reported
None reported
Manufactured in
350 Merrimack St, Lawrence, Massachusetts, United States
Classification
Class II
Recall number
D-0169-2027

In the FDA's words

Description
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,500 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT. NO. 054-25321. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-206-94 Lack of Assurance of Sterility:complaints have been received related to potential leaks from small perforations in the print area on the primary bag in the affected lots. Lot#: 25HGPD037, Exp 12/31/2026; 26CGPD074, Exp 9/30/2027. Distribution: Nationwide in the USA. Affected quantity: 1,065 cases (5 bags per case)
Hazard
Lack of Assurance of Sterility:complaints have been received related to potential leaks from small perforations in the print area on the primary bag in the affected lots.

5 products in this recall

The agency lists each product separately. Check every one you might have.

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