CLASS II ONGOING Drug recall · Reported 10 Jan 2024 · FDA Enforcement Report
Delflex Peritoneal Dialysis Solution recalled by Fresenius Medical Care
Fresenius Medical Care Holdings is recalling Delflex Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, distributed nationwide in the US. The recall was initiated on 28 Dec 2023 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-0218-2024
- FDA event ID
- 93690
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Brand
- Delflex
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Dec 2023
- FDA classified
- 4 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Dec 2023 | Recall initiated by company | |
| 4 Jan 2024 | Classified by FDA | +7 days |
| 10 Jan 2024 | Published in enforcement report | +6 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 Sterility Assurance
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 in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance
Which lots are affected?
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Where was it sold?
Nationwide within the United States
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 Holdings
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5008X Blood Tubing Set recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide |
| Device | CLASS II | Bicarby" Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Packaging Defects | Nationwide |
| Device | CLASS II | Bicarby Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | TX |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
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 |