MedicaLyte Concentrate Recall Follows Reports of Contamination, Injury and Death

“Visual irregularities” led to discovery of bacterial and fungal contamination in what should be a sterile liquid used in certain kidney procedures.

Nipro is recalling its MedicaLyte dialysis liquid due to concerns over bacterial and fungal contamination, following reports of one death and another serious injury.

The U.S. Food and Drug Administration (FDA) announced the Class I MedicaLyte liquid bicarbonate concentrate recall on June 13, warning that exposure to the contaminated fluid could lead to bloodstream infections, sepsis, organ failure or even death.

MedicaLyte Liquid Bicarbonate Concentrate is a dialysate, a sterile electrolyte solution used in hemodialysis to help remove waste, toxins and excess fluids from the blood of patients with kidney failure. During the dialysis process, the solution plays a critical role in balancing electrolytes and supporting filtration.

Officials are warning the use of contaminated MedicaLyte may result in serious health risks, including infections, treatment interruptions, sepsis and potentially fatal outcomes. Long-term complications may include chronic infections, organ damage and a weakened immune system.

After reports of “visual irregularities” in the liquid, certain MedicaLyte samples were sent to third-party laboratories for testing, which confirmed the presence of bacterial and fungal contaminants.

Based on these findings, Nipro is removing the product from the market and advising healthcare facilities to do the same. The company has warned medical professionals that any hemodialysis machine exposed to the recalled MedicaLyte must be thoroughly disinfected, following the manufacturer’s cleaning guidelines.

The recall affects MedicaLyte Liquid Bicarbonate Concentrate – 45x Proportioning (BC+201), identified by the unique device identifier model number 00817411022824.

On June 2, Nipro issued a warning letter to customers advising them to stop using the product immediately. The company recommended halting all dispensing and distribution, quarantining all affected lots, and forwarding the recall notice to any recipients of the recalled product.

Customers can contact Nipro with any questions about the recall at 1-877-546-0126.

The FDA urges customers and healthcare professionals to report any side effects or adverse events to the FDA’s MedWatch Adverse Event Reporting Program.

Nurse Assist Saline and Sterile Water Recall Lawsuits

The MedicaLyte recall comes amid growing concerns over contamination risks involving sterile medical fluids. In late 2023, Nurse Assist recalled a range of sterile saline and sterile water products after discovering that a packaging defect may have allowed bacteria to enter the sealed containers, compromising the sterility of the solutions.

These products, which were intended for use in wound care, irrigation and medical device cleaning, were widely distributed under various brand names throughout the U.S. and Canada. 

Since the recall, multiple Nurse Assist recall lawsuits have been filed by patients who developed serious infections after using the contaminated products, including bloodstream infections, sepsis and organ failure.

The lawsuits allege that Nurse Assist failed to follow appropriate manufacturing procedures and did not adequately warn consumers or healthcare providers about the risks. 

In one high-profile case, a 26-year-old man died from septic shock and cardiac arrest after using the recalled sterile saline solution to treat leg wounds. His family has filed a wrongful death lawsuit, claiming the infection was directly caused by the contaminated product.

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