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Moderate riskFDA DrugClass II

DELFLEX dialysis solution recalled for possible sterility concern

Fresenius Medical Care is recalling DELFLEX peritoneal dialysis solution because the primary bag may have small perforations in its print area, which could cause leaks. The company has received complaints about potential leaks, and the agency reports a lack of assurance of sterility. 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 for lot 25NGPD001, expiration date 4/30/2027, NDC 46163-212-94, catalog number 054-25324 (2,500 mL single-dose bag, 116 cases of 5 bags).
  3. The notice doesn't say how to get a replacement or refund; contact Fresenius Medical Care or where you received the product.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
DELFLEX Peritoneal Dialysis Solution with 4.25% 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. 054-25324. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-212-94
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
116 cases (5 bags per case)
Illnesses reported
None reported
Manufactured in
350 Merrimack St, Lawrence, Massachusetts, United States
Classification
Class II
Recall number
D-0171-2027

In the FDA's words

Description
DELFLEX Peritoneal Dialysis Solution with 4.25% 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. 054-25324. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-212-94 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: 25NGPD001, Exp 4/30/2027 Distribution: Nationwide in the USA. Affected quantity: 116 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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