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NaturaLyte Recall Issued Over Bacterial Contamination

In April 2014, Fresenius Medical Care (FMC) announced a nationwide recall for NaturaLyte, a liquid bicarbonate product used in hemodialysis procedures. This action was taken after it was discovered that certain lots of NaturaLyte may be contaminated with a bacteria called Halomonas, which can cause life-threatening systemic infections. This is a Class I Recall, which means that use of NaturaLyte may carry a risk of adverse health consequences or even death.

Free NaturaLyte Lawsuit Evaluation: If you or a loved one was injured after being treated with NaturaLyte, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Fresenius Medical Care and we can help.

Why was the NaturaLyte Recall Issued?

According to a MedWatch Safety Alert issued by the U.S. Food & Drug Administration (FDA) on May 22, 2014, at least 56 lots of NaturaLyte were found to be contaminated with Halomonas bacteria, resulting in a Class I recall of the affected lots. These products were sold in 6.4 liter bottles, and distributed between August 15, 2013 and April 7, 2014. The product code of affected lots is 08-4000-LB, with expiration dates of 6/30/2014, 7/31/2014, 8/31/2014, and 12/31/2014.

What is Halomonas?

Halomonas is a Gram Negative bacteria typically found in water with high salt content.
Dialysis patients treated with tainted NaturaLyte products may develop bacteremia or systemic infections, which can cause:

  • Fever
  • Hypotension
  • Flushing
  • Chills
  • Trouble breathing

However, Fresenius has indicated that the dialysis procedure utilizes both a dialysis filter called a dialyzer, as well as the use of the Diasafe filter or an equivalent which makes infection unlikely to occur.

Recommendation

Fresenius has requested that dialysis clinics with remaining stocks of NaturaLyte included in this recall:

  • Stop using them immediately
  • Place them in a segregated area
  • Disinfect any machine on which NaturaLyte was used
  • Contact the company for instructions on how to return the recalled NaturaLyte product

2012 NaturaLyte Recall

In March 2012, a nationwide recall for NaturaLyte and GranuFlo (another dialysis treatment product made by FMC) was issued by the FDA after it was determined that use of the products could lead to increased levels of bicarbonate in the blood. In announcing the recall, FDA stated that Fresenius had failed to disclose important safety information to healthcare providers about the risk of elevated bicarbonate levels associated with NaturaLyte and GranuFlo. Due to this negligence, thousands of dialysis patients were put at unnecessary risk of developing adverse health complications.

Can I File a NaturaLyte Lawsuit?

Only a qualified attorney can determine whether you are eligible to file a lawsuit against Fresenius Medical Care, the maker of NaturaLyte, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.

Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of NaturaLyte, our attorneys suspect that patients may be able to take legal action in light of claims that Fresenius failed to adequately warn doctors and patients about the risk of bacterial contamination and/or elevated bicarbonate levels.

How Can Filing a Lawsuit Help Me?

By filing a lawsuit against the maker of NaturaLyte, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.

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