Drug 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.
D-0218-2024
Product summary
- Event
- Event 93690
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 69,590 bags
- Official record key
drug-enforcement:D-0218-2024
Official wording
Reason: Lack of Sterility Assurance
Code information: Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Sterility