Naturalyte Recalled for Bacterial Contamination Risk

May 23, 2014 — Fresenius Medical Care initiated a recall of 56 lots of Naturalyte Liquid Bicarbonate Concentrate due to potential bacterial contamination. Patients could develop sepsis or bacteremia (blood poisoning).

According to the Class I recall notification, laboratory testing identified the bacteria as Halomonas, which is typically found in salty water:

“The affected lots were produced in its Montreal, Canada facility and are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.”

There are a few case reports in medical literature describing bacteremia (blood poisoning) and sepsis associated with bacterial contamination of dialysate solution. However, this risk is significantly reduced by using a dialysis filter and a Diasafe filter, which creates an effective bacteria and endotoxin barrier.

The recalled products were sold in 6.4 liter bottles, which were distributed from August 15, 2013 through April 7, 2014. The affected lots have a product code of 08-4000-LB, with expiration dates of 6/30/2014, 7/31/2014, 8/31/2014, and 12/31/2014.

Fresenius warns that pyrogenic reactions can occur when a patient is exposed to a significant amount of endotoxins, which are present in bacteria. This could lead to complications including:

  • Fever
  • Hypotension (low blood pressure)
  • Flushing
  • Chills
  • Breathing difficulties.

Although the effects of endotoxins are only temporary, patients can potentially develop long-term health problems from serious health problems. In addition, a high amount of bacteria in the dialysis concentrate could lead to transient bacteremia (blood poisoning).

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