CLASS II Drug recall · Reported 28 Mar 2018 · FDA Enforcement Report
Delflex Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single recalled
Fresenius Medical Care Renal Therapies Group is recalling Delflex Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single, distributed nationwide in the US. The recall was initiated on 20 Dec 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0604-2018
- FDA event ID
- 79403
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, Waltham, MA
- Brand
- Delflex
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2017
- FDA classified
- 20 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Dec 2017 | Recall initiated by company | |
| 20 Mar 2018 | Classified by FDA | +90 days |
| 28 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Where it was distributed
Product was distributed throughout the United States to patients and clinics.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Which lots are affected?
Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
Where was it sold?
Product was distributed throughout the United States to patients and clinics.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Medical Care Renal Therapies Group
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|---|---|---|---|---|---|
| Device | CLASS II | 5008X HD/HDF with CLiC Blood Tubing Set recalled | Fresenius Medical Care Renal Therapies Group | Packaging Defects | Nationwide |
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Other Dextrose recalls
All 44| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Dextrose Injection recalled by B Braun MedicalDextrose | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |