Bacterial Contamination Prompts Recall of Concentrate Used in Dialysis

May 30, 2014

Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said.

Fifty-six lots of Fresenius’s NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters, were pulled during the past two months because the product may develop higher bacteria levels than is allowed by the company’s internal specification, according to the recall notice.

Fresenius’ first customer notification of the Class I recall went out April 10 for 49 lots of the concentrate and the second was sent out May 1 warning of an additional nine lots.

Fresenius said the concentrate was manufactured at its facility in Montreal, Canada, and was distributed between August 2013 and April 7 of this year.

“Laboratory testing has identified the bacteria as Halomonas (species 1, 2, 3), a Gram Negative bacteria, typically found in water with high salinity,” the company said, noting that dialysate contamination has been linked with bacteremia and systemic infection.

Infection is unlikely, however, because of filters used in delivering dialysis create an effective bacteria and endotoxin barrier,” the FDA said.

The FDA announcement made no mention of any reports of people being sickened. In its second letter to customers, Fresenius said that “no pyrogenic reactions, bacterial infections or related adverse events have been reported.”

Fresenius is a division of Fresenius Medical Care, which supplies more than 2,150 dialysis centers throughout North America with dialysis equipment and products as well as renal pharmaceuticals.

Fresenius did not respond to requests for comment by press time.

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