Warning
Fresenius Medical Care Holdings Recalls DELFLEX
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0512-2026Drug / Pharmaceutical
Fresenius Medical Care Holdings Recalls DELFLEX
Fresenius Medical Care Holdings, Inc. · Class II — Moderate Risk
Product Description
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 for Recall
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Fresenius Medical Care Holdings, Inc. initiated the recall on April 6, 2026 affecting 37,215 bags. Lack of Assurance of Sterility: Potential leaks from perforations in bags. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Fresenius Medical Care Holdings, Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.