The U.S. Food and Drug Administration said it has received one report of death and two reports of injury that may be related to use of recalled lots of Fresenius Medical Care North America's NaturaLyte liquid bicarbonate concentrate.
"This week, subsequent to the recall, the FDA updated its website with information that it received," Jon Stone, spokesperson for Fresenius Medical Care, told NN&I. "We are looking into these reports."
According to Stone, FMCNA initiated the voluntary recall when they discovered through testing that certain lots of the product, which fell within acceptable bacteria levels for release into the market, later revealed increased bacteria levels. FMCNA has identified the bacteria as Halmonas,a Gram Negative bacteria, typically found in water with high salinity (salt concentration).
"According to a few case reports in the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection," FMCNA said in a May 21 news release. "The dialysis filter (dialyzer) and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that makes this event unlikely."
FMCNA initiated the recall, which included 49 lots, on April 4. The company expanded the recall to include nine additional lots on May 1. On May 21, the recall was classified as Class 1. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
Anyone with one or more bottles of the affected product should do the following:
- Discontinue use immediately.
- Place all units in a secure, segregated area.
- If affected product was on the machine prior to patient treatment, perform a heat disinfect program
- Contact FMCNA 800.323.5188 for instructions on how to return the recalled product.
The affected NaturaLytelots include the following:
Lot numbers recalled on April 10
Expanded recall on May 1