DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92
Drug Recall
Official source record
- Recall number
- D-0607-2021
- Event ID
- 87907
- Classification
- Class III
- Status
- Terminated
- Recalling company
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Report date
- June 16, 2021
- Recall initiation date
- April 28, 2021
- Termination date
- September 17, 2021
- Distribution pattern
- Nationwide within the United States
Drug product identifiers
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Brand name
- DELFLEX
- Generic name
- DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
- Substance names
- CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
- Product NDCs
- 49230-206; 49230-209; 49230-212
- Package NDCs
- 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95
- Route
- INTRAPERITONEAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details, or FDA Enforcement Reports versus recall announcements for why that gap exists. New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.
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Frequently asked questions
What does a Class III mean?
FDA classifies this recall as Class III. See how to read an FDA recall record for what each classification level means.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Official guidance and record verification
Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.
How to interpret this historical record
This record is preserved as published by FDA, as of September 17, 2021.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.