DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialy… recall
Fresenius Medical Care Holdings, Inc. recalled DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialy… on May 13, 2026 because of lack of Assurance of Sterility: Potential leaks from perforations in bags. It was sold nationwide.
Why it was recalled
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
What's recalled
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.
Quantity: 43,225 bags
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Fresenius Medical Care Holdings, Inc., Waltham, MA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide in the USA - Status
- Ongoing
- Recall number
- D-0513-2026
- Source
- U.S. Food and Drug Administration
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