Drug recall D-0604-2018
Product
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Reason for recall
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Lots and codes
Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
Recall details
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA
- Quantity
- 3,734 cases
- Distribution
- Product was distributed throughout the United States to patients and clinics.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 20, 2017
- Terminated
- February 14, 2019
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