Particulate matter contamination has led to the recall of two lots of DIANEAL dialysis solution by Baxter International.
The Baxter Peritoneal Dialysis Solution recall was announced by the FDA on August 13.
While Baxter says it has not received word of any adverse events, the company warns that the solutions may be contaminated with particulate matter from stainless steel, garment fiber, and PVC due to a problem in the manufacturing process.
The solution is used during peritoneal dialysis in patients with chronic renal failure to assist in cleaning the blood. Baxter warns that the particulate matter can cause local inflammation, result in adhesion formation, or could serve as a focal point for infections that could result in death.
The recall affects two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II). The recall affects lots C940700 and C940841. Both lots have a product code of L5B5202, an NDC number of 0941-0457-05, and an expiration date of May 31, 2016. The affected lots were distributed between May 30 and July 9.
This is the second Baxter DIANEAL recall within the last five months. The company issued another DIANEAL dialysis solution recall on March 5, again due to particulate matter contamination. In that case the contaminants turned out to be mold.
With that prior recall, a number of adverse patient events were reported involving dialysis problems among patients given the solution.
Baxter reports that it has sent letters to affected customers instructing them to locate and remove affected product. The company also contacted patients with a recall letter with instructions on returning the recalled solutions.
Consumers with questions can call Baxter Home Care Services at 1-800-284-4060 and healthcare providers can receive credit for returning the recalled solutions by calling Baxter Healthcare Center for Service at 1-888-229-0001.
The company and the FDA urge that adverse events associated with the solutions be reported to the FDA MedWatch adverse event reporting program.
GranuFlo and NaturaLyte Dialysis Recall
The Baxter dialysis solution recall comes about two years after Fresenius, the largest dialysis product provider in the country, notified its facilities that its GranuFlo and NaturaLyte dialysis solutions could cause heart attacks if used incorrectly. The FDA later determined that action to be a GranuFlo and NaturaLyte recall.
Fresenius now faces hundreds of dialysis treatment lawsuits in federal and state courts nationwide, all involving similar allegations that the company failed to provide adequate warnings about the risk of heart problems from GranuFlo or NaturaLyte dialysis solutions.
In April 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all Fresenius cases filed throughout the federal court system, centralizing all lawsuits before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the witnesses, parties and the courts.
A number of cases have also been filed against Fresenius in Massachusetts state court, where similar centralization has been established to place the litigation before one judge.