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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 Me…

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

Class II Medicine & devices FDA May 13, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Fresenius Medical Care Holdings, Inc. — Waltham, MA
Severity
Class II — moderate
Reported
May 13, 2026
Quantity
37,215 bags
Recall number
D-0512-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide in the USA

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