CLASS II Drug recall · Reported 26 May 2021 · FDA Enforcement Report
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC recalled
Fresenius Medical Care North America is recalling Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, distributed nationwide in the US. The recall was initiated on 14 Apr 2021 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-0389-2021
- FDA event ID
- 87809
- Recalling firm
- Fresenius Medical Care North America, Ogden, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Apr 2021
- FDA classified
- 19 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Apr 2021 | Recall initiated by company | |
| 19 May 2021 | Classified by FDA | +35 days |
| 26 May 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Which lots are affected?
Lot #20SU03019, Exp 6/2022
Where was it sold?
USA Nationwide
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.
Other Delflex Peritoneal Dialysis recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recalled | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide |