Recall Weekly
Moderate riskFDA DrugClass II

DELFLEX dialysis solution recalled for lack of sterility assurance

Fresenius Medical Care is recalling certain lots of DELFLEX peritoneal dialysis solution 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. The product was distributed nationwide, and the notice reports no injuries.

From the FDA notice · Read the official notice ↗

What to do

  1. Talk to your pharmacist or prescriber before stopping it.
  2. Check the lot number on the bag. Affected lots are 25JGPD069 (exp 1/31/2027); 25SGPD046, 25SGPD059, 25SGPD063 (exp 6/30/2027); and 26EGPD022 (exp 11/30/2027). The product is CAT. NO. 054-25322, NDC 46163-209-94.
  3. The notice doesn't say how to get a refund or replacement; contact Fresenius Medical Care or where you obtained the product.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
DELFLEX Peritoneal Dialysis Solution with 2.5% 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. 054-25322. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-209-94
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
2,709 cases (5 bags per case)
Illnesses reported
None reported
Manufactured in
350 Merrimack St, Lawrence, Massachusetts, United States
Classification
Class II
Recall number
D-0170-2027

In the FDA's words

Description
DELFLEX Peritoneal Dialysis Solution with 2.5% 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. 054-25322. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-209-94 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#: 25JGPD069, Exp 1/31/2027; 25SGPD046, 25SGPD059, 25SGPD063, Exp 6/30/2027; 26EGPD022, Exp 11/30/2027. Distribution: Nationwide in the USA. Affected quantity: 2,709 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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