D-0218-2024 Class II Ongoing
FDA drug recall D-0218-2024 was initiated by Fresenius Medical Care Holdings, Inc. on December 28, 2023 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is ongoing. Affected quantity: 69,590 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- January 10, 2024
- Initiation Date
- December 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,590 bags
Product Description
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
Distribution Pattern
Nationwide within the United States
Code Information
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025