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Fresenius Medical Care Holdings, Inc.: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L

DrugsSource: FDA (drug) · Date: 2026-05-13

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Fresenius Medical Care Holdings, Inc.
Product
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 / hazard
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-04-06
Code info
Lot #: 25CU02007, 25CU02008, 25CU02009
Product quantity
37,215 bags
Voluntary mandated
Voluntary: Firm initiated
City
Waltham
State
MA
Country
United States
Event id
98829
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