DELFLEX Peritoneal Dialysis Solution in Biofine recall: Sterility Concern
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.
Why was DELFLEX Peritoneal Dialysis Solution in Biofine recalled?
Lack of Sterility Assurance
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
- 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.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 69,590 bags
- Distribution
- Nationwide within the United States
- Recall date
- January 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)