Class II
Ongoing
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.
This recall is currently active, issued January 10, 2024. It was issued by Fresenius Medical Care Holdings, Inc..
- Recall Initiated
- December 28, 2023
- Posted
- January 10, 2024
- Recall Number
- D-0218-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 69,590 bags
- Firm Location
- Waltham, MA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Sterility Assurance
Distribution
Nationwide within the United States
Lot / Code Info
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
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