Recall Weekly
Moderate riskFDA DrugClass II

DELFLEX dialysis solution recalled for potential sterility risk

Fresenius Medical Care recalled certain lots of DELFLEX Peritoneal Dialysis Solution, 2,000 mL single dose bags, for lack of assurance of sterility. Complaints reported possible leaks from small perforations in the print area of the primary bag. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Talk to your pharmacist, prescriber, or dialysis care team before stopping or changing your treatment.
  2. Check the lot number on the bag and case. Affected lots are 25DGPD002, 25DGPD003, 25KGPD027, 25KGPD042, 25SGPD033, 26AGPD033, and 26AGPD054, all with NDC 46163-209-92.
  3. The notice doesn't say how to get a replacement or refund; 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, 2,000 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT. No. 054-20222. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-209-92
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
6,283 cases (5 bags per case)
Illnesses reported
None reported
Manufactured in
350 Merrimack St, Lawrence, Massachusetts, United States
Classification
Class II
Recall number
D-0168-2027

In the FDA's words

Description
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,000 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT. No. 054-20222. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-209-92 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 # 25DGPD002, 25DGPD003, Exp 10/31/2026; 25KGPD027, 25KGPD042, Exp 2/28/2027; 25SGPD033, Exp 6/30/2027; 26AGPD033, 26AGPD054, Exp 7/31/2027. Distribution: Nationwide in the USA. Affected quantity: 6,283 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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