Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Sterility Assurance
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
Affected NDC
49230-0206-62
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Delflex Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride NDC 49230-0206 |
DEXTROSE MONOHYDRATE 1.5 g/100mL; SODIUM CHLORIDE 538 mg/100mL; SODIUM LACTATE 448 mg/100mL; CALCIUM CHLORIDE 18.4 mg/100mL; MAGNESIUM CHLORIDE 5.08 mg/100mL | Solution Intraperitoneal |
Fresenius Medical Care Renal Therapies Group, LLC | Rx |
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- NDC code
- 49230-206-62
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0218-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Fresenius Medical Care Holdings, Inc.
All 2023 recalls
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
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All sterility / contamination recalls
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