Class III · Low risk
Magnesium Chloride
Subpotent drug
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
Affected NDC
49230-0212-94
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
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 49230-0212 |
DEXTROSE MONOHYDRATE 4.25 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
- 49230-212-94
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0608-2024 · 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 Magnesium recalls
See all
Class I · High risk
Magnesium Sulfate in Water for Injection
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class II · Moderate risk
Magnesium Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Other recalls by Fresenius Medical Care Holdings, Inc.
All 2024 recalls
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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 in Biofine container 1.5% Dextrose
Lack of Sterility Assurance
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