DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, 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
Lot #: 25CU02007, 25CU02008, 25CU02009
Date
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