Nxstage Medical Inc: Delflex Peritoneal Dialysis Solution With 1.5% Dextrose, Low Magnesium/ Low Calcium And Attached Stay Safe Exchange Set, 2
- Recalling firm
- NxStage Medical Inc
- Product
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,500 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT. NO. 054-25321. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-206-94
- Reason
- Lack of Assurance of Sterility:complaints have been received related to potential leaks from small perforations in the print area on the primary bag in the affected lots.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/59c0c87d-5f21-4503-8d50-67fd030796dc