DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Reason
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Classification
Class II
Status
Ongoing
Lot
Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Fresenius Medical Care Holdings, Inc. — Class II Recall | MedicineWatch US