Recall Weekly
Moderate riskFDA DrugClass II

DELFLEX dialysis solution recalled for possible loss of sterility

Fresenius Medical Care is recalling certain lots of DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 2,000 mL single-dose bags with an attached stay safe Exchange Set. Complaints reported potential leaks from small perforations in the print area of the primary bag, so the solution may not be sterile. 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 it.
  2. Check the lot numbers: 25JGPD045, 25JGPD046, 25JGPD060 (exp 1/31/2027), and 25KGPD057 (exp 2/28/2027). The product is NDC 46163-206-92, Cat. No. 054-20221.
  3. The notice doesn't say how to get a replacement or refund; ask Fresenius Medical Care or your dialysis provider.
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, 2,000 mL - Single Dose Bag, Sterile and Non-Pyrogenic, Rx only, CAT.NO. 054-20221. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-206-92
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
4,232 cases (5 bags per case)
Illnesses reported
None reported
Manufactured in
350 Merrimack St, Lawrence, Massachusetts, United States
Classification
Class II
Recall number
D-0167-2027

In the FDA's words

Description
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,000 mL - Single Dose Bag, Sterile and Non-Pyrogenic, Rx only, CAT.NO. 054-20221. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-206-92 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 #: 25JGPD045, Lot 25JGPD046, Lot 25JGPD060, Exp 1/31/2027; 25KGPD057, Exp 2/28/2027. Distribution: Nationwide in the USA. Affected quantity: 4,232 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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