FDAFDA · Food and drugs·Recall number D-0218-2024
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.
Published January 10, 2024 · Recall initiated: December 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Sterility Assurance
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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