Drug recall D-0218-2024
Product
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.
Reason for recall
Lack of Sterility Assurance
Lots and codes
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA
- Quantity
- 69,590 bags
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 28, 2023
Related products
- Delflex – drug information
- NDC 49230-209 Delflex · Sodium Chloride 538 mg/100mL; Sodium Lactate 448 mg/100mL;… · Fresenius Medical Care Renal Therapies Group, LLC
- NDC 49230-212 Delflex · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Fresenius Medical Care Renal Therapies Group, LLC
- NDC 49230-206 Delflex · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Fresenius Medical Care Renal Therapies Group, LLC