United StatesDELFLEX Dextrose Peritoneal Dialysis Solution with attached stay‑safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% (Part 054‑20221; lots 25CU02007, 25CU02008, 25CU02009) and 2.5% (Part 054‑20222; lots 25CU02002, 25CU02011, 25CU02012, 25CU02013), 2L 5PK, distributed by Fresenius Medical Care North America and sold nationwide in the USA, is being recalled. The products were recalled due to lack of assurance of sterility from potential leaks caused by perforations in the bags.
What's being recalled
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.
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.
Recalling firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, United States.
How to identify it
Lot #: 25CU02007, 25CU02008, 25CU02009 Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
The hazard
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)