DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and a… recall
FDA recall D-0608-2024 · initiated Jun 18, 2024
Fresenius Medical Care Holdings, Inc. recalled DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXT… in Jun 2024 — an FDA Class II recall (D-0608-2024) because This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 183 cases
Details
- Product
- 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
- Recalling company
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Jun 18, 2024
- FDA report date
- Jul 24, 2024
This recall is linked to a product we cover: Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium in Plastic Container →
Frequently asked
- Was DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXT… recalled?
- Fresenius Medical Care Holdings, Inc. recalled DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXT… in Jun 2024 — an FDA Class II recall (D-0608-2024) because This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXT… recalled?
- Per the FDA enforcement record, the reason for recall D-0608-2024 was: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
- Is a recalled DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXT… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXT… are affected?
- Distributed: Nationwide. The recall covers these lots — 24AU03024, exp. date 07/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0608-2024.