The U.S. Food and Drug Administration (FDA) announced May 28 that Fresenius
Medical Care North America's voluntary recall of 58 lots of
NaturaLyte Liquid Bicarbonate Concentrate 6.4-liter bottles has been classified as a Class I recall due to concerns of potential bacterial
According to the FDA, a Class I recall is "the most serious type of
recall" and reserved for situations in which there is a "reasonable
probability" that the recalled product "will cause serious adverse
health consequences or death."
In a May 21 press release, Fresenius said it had issued a
recall of the NaturaLyte bottles "because they may develop higher bacteria levels than is allowed
by the company's internal specifications during their shelf life."
According to the FDA, the agency has received one report of death and two
reports of injury "that may be related" to use of the NaturaLyte products.
Fresenius reports that the affected lots were produced at its facility
in Montreal, Canada. The lots were manufactured between August 2013 and
April 2014 and distributed from August 15, 2013 to April 7, 2014, the
Fresenius recalled 49 lots on April 10, 2014 and added nine more lots to
the recall on May 1, 2014. The recall initiation date is listed by the
FDA as April 4, 2014.
This recall should not be confused with the March 2012 Class I recall of
GranuFlo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate dialysis products.
Lab Testing Reveals Bacteria
NaturaLyte Liquid Bicarbonate Concentrate is used in the treatment of acute
and chronic renal failure during hemodialysis.
It is one of many dialysis products manufactured and distributed across
North America by Fresenius Medical Care North America. The company also
operates thousands of dialysis clinics in the U.S., including several
located in Florida.
The FDA reports that lab testing identified the bacteria at the heart of
this recall as being Halomonas (species 1, 2, 3), or a gram negative bacteria
typically found in water with a high salt concentration.
Centers for Disease Control and Prevention describes gram negative bacteria as being "resistant to multiple
drugs' and "increasingly resistant to most available antibiotics."
The FDA states that use of a contaminated product could cause sepsis, bacteremia
(bacteria entering the bloodstream) and death.
As part of the recall, the FDA has urged customers to examine their stock
to determine whether it contains a recalled product, immediately discontinue
use, segregate the products in a secure area and perform a "Heat
Disinfect" program if the product was placed on a machine prior to
patient treatment. Fresenius has asked for the products to be returned.
Drug Recalls Remain an Ongoing Concern
A study published in 2012 in the Archives of Internal Medicine found that
drug recalls happen at a rate of about one per month in the U.S.
The study by researchers from Brigham and Women's Hospital in Boston
suggested that, even once a recall is issued, the process in place for
notifying health care providers of dangerous drugs may not be enough to
ensure patient safety,
ABC News reported.
If you or a loved one believes they have been treated with a recalled and
dangerous drug, it is important to immediately seek medical advice from your doctor as
well as legal advice from an attorney with experience in handling defective
product cases. The attorney can help you to understand your legal rights
and take steps to make sure those rights are protected.