Sterile Saline Solution Recall Lawsuit

Nurse Assist Recall Lawsuit Overview

Nurse Assist produces both saline solutions and sterile water products, which may be packaged in syringes, bottles, spray cans or medical kits under various different brands that are widely used by medical providers throughout the U.S.  However, in late 2023, it was discovered that the sterile solutions may be contaminated with harmful bacteria, which could cause severe or life-threatening infections. 

The saline solutions blend precise amounts of sodium chloride with purified water,  which is designed for rinsing and cleansing medical devices, as well as wounds. The sterile water products are free from any added salts, and are intended for medical uses that require salt-free solutions.

In November 2023, a Nurse Assist  saline and sterile water solutions recall was issued, after it was discovered that a packaging seal defect could compromise the sterile barrier and allow bacteria to enter the products.  This created a serious infection risk for patients throughout the U.S., particularly if they have compromised immune systems, are elderly, or have chronic conditions.

Nurse Assist recall lawsuits are now being investigated by lawyers nationwide, alleging that Nurse Assist LLC neglected their duty to provide safe, sterile medical products and failed to adequately warn consumers and healthcare providers about the risks associated with the contaminated products.

Who is Eligible for a Nurse Assist Recall Lawsuit?

Lawyers provide free consultations and claim evaluations to help families determine if financial compensation may be available through a Nurse assist recall lawsuit settlements for individuals who used the sterile cleaning solutions and developed any of the following side effects, injuries, or severe complications:

• Sepsis (septic shock)
• Bloodstream infections
• Respiratory infections
• Organ failure
• Necrosis
• Cardiac arrest
• Wrongful death
• Urinary Tract Infections (UTIs)
• Other injuries caused by bacterial infections

2024 Nurse Assist Recall Lawsuit Updates

November 6, 2024 Update: One of the first Nurse Assist recall lawsuits was filed on November 5, 2024, alleging that contaminated sodium chloride saline solution caused a 26 year old man to develop a severe infection, which sent him into septic shock and cardiac arrest, ultimately killing him.

April 15, 2024 Update: The FDA issued a Safety Communication today announcing a Nurse Assist sterile water and saline solution recall expansion, which now includes additional medical products and manufacturers of kits and trays that contain potentially contaminated Nurse Assist recalled products.

November 6, 2023 Update: The U.S. Food and Drug Administration (FDA) announced the Nurse Assist sterile water and saline recall on November 6, indicating the manufacturer found the packaging seal may potentially break and compromise the sterile barrier, which can introduce harmful bacteria into the solution.

Sodium Chloride Irrigation and Sterile Water Recalls

The U.S. Food and Drug Administration (FDA) first announced the Nurse Assist recall on November 6, 2023, impacting numerous water-based medical products including various sizes of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP.

According to the manufacturers voluntary recall notice, the water-based medical products may not be sterile and could potentially be contaminated with bacteria that could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound/soft tissue, and respiratory infections.

The recall included:

• 0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes);
• Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes).

Officials warned that the products were distributed individually and possibly in repackaged medical convenience kits throughout the United States and Canada, under various brands from November 1, 2021 to September 18, 2023.

Although the FDA indicates at that time that there had been no reports of patient harm reported, healthcare professionals and individuals were instructed to immediately check their inventory and stop using the affected products. However, a number of reports are now beginning to emerge involving severe and sometimes fatal infections caused by the contaminated sterile solutions.

April 2024: Expanded Recall of Nurse Assist Products

While the initial recall warned that Nurse Assist sterile saline and water products may have been repackaged in medical kits, details about which specific products were impacted was not confirmed at the time.

However, a Nurse Assist recall expansion was announced in April 2024, in direct response to a number of adverse events emerging from the use of impacted saline or sterile water products repacked in medical kits and trays.

• Cardinal Health: Cardinal Health and Covidien issued a urology and operating room kit recall in April for Covidien and Cardinal Health brand urology and operating room kits and trays containing Nurse Assist’s 0.9% sodium chloride irrigation USP and sterile water for irrigation USP. The recall was due to potential contamination concerns that could have compromised sterility and posed infection risks to patients.
• Busse Hospital Disposables: Busse Hospital Disposables recalled tracheostomy care and dressing change kits that included Nurse Assist’s Stericare 100ML sterile saline bottle. The recall addressed possible sterility issues that might have led to infections during medical procedures.
• ROi CPS LLC: ROi CPS, LLC recalled Regard Operative Lap P&S surgical trays containing Nurse Assist’s irrigation solution due to a sterility defect. This defect could have increased the risk of infections in patients who underwent surgical procedures.
• Windstone Medical Packaging dba Aligned Medical Solutions: Windstone Medical Packaging recalled ocular packs and closure kits containing Nurse Assist sterile saline components due to potential sterility issues. These packs, commonly used in ocular, extremity, and closure procedures, posed potential infection risks to patients.
• Maquet Cardiovascular, LLC: Maquet Cardiovascular recalled Atrium Express chest drains, which included syringes prefilled with Nurse Assist water-based products. The recall addressed sterility concerns that may have posed infection risks for patients who used these drains.
• Avanos Medical, Inc: Avanos Medical recalled MIC* Gastric-Jejunal feeding tube kits due to sterility issues with Nurse Assist supplied syringes. These syringes, essential for inflating retention balloons, could potentially have led to contamination and patient infection.
• Medline Industries, LP: Medline Industries recalled Medline and Centurion convenience kits containing Nurse Assist irrigation solutions, used in both home and medical settings. The recall aimed to prevent infection risks linked to potential sterility issues with the included irrigation products.

Which Brands of Saline and Sterile Water Were Recalled?

The following brands of saline and sterile water medical products have been recalled over bacterial contamination risks:

• Nurse Assist
• Stericare
• Cardinal Health
• Covidien
• Idex
• McKesson
• Mac Medical
• Medline
• SOL
• Trudell
• Vyaire
• Halyard Owens Minor
• Medichoice Owens Minor

Contaminated Saline and Water Side Effects

Exposure to bacteria in contaminated Nurse Assist saline and water solutions can lead to a range of serious and potentially life-threatening infections and side effects, which could include:

• Sepsis (Septic Shock): Bacteria entering the bloodstream can trigger sepsis, a life-threatening reaction where the body’s immune system attacks its own organs and tissues. This can escalate to septic shock, causing dangerously low blood pressure and leading to organ damage or death.
• Bloodstream Infections (BSI): Contaminated solutions can introduce bacteria directly into the bloodstream, leading to bloodstream infections that spread rapidly and are difficult to treat, particularly among those with weakened immune systems.
• Respiratory Infections: Bacteria from contaminated solutions can lead to respiratory infections if they spread to the lungs, causing conditions like pneumonia, which may be severe in hospitalized or vulnerable patients.
• Urinary Tract Infections (UTIs): Contamination may cause bacteria to enter the urinary tract, leading to painful infections that can progress to the kidneys or bloodstream, particularly dangerous in patients with compromised immunity.
• Organ Failure: Widespread bacterial infections can severely damage vital organs, such as the kidneys, liver, or lungs, eventually leading to organ failure if the body is unable to combat the infection.
• Necrosis: Bacterial infections can cause tissue death (necrosis) if blood flow to certain areas is disrupted, particularly in cases where the infection becomes localized and prevents oxygen and nutrient supply.
• Cardiac Arrest: The strain from a severe infection or septic shock can overwhelm the heart, potentially leading to cardiac arrest, especially in patients with preexisting heart conditions or under high-stress situations.
• Wrongful Death: In extreme cases, infections that are not controlled can lead to fatal outcomes, particularly in vulnerable populations such as the elderly, immunocompromised, or critically ill.
• Other Bacterial Infections: Contaminated solutions can lead to various other infections, such as skin infections, abscesses, or soft tissue infections, which, while not immediately life-threatening, can result in severe complications if not properly treated.

Proving Exposure to Contaminated Saline or Water Solutions

To prove exposure to recalled saline or sterile water solutions distributed through hospitals, home prescriptions, and retailers, lawyers can obtain medical records showing usage during treatments, request purchase histories from pharmacies, or gather receipts from retailers.

Exposure Through Hospital Administration

If you received saline or water-based solutions during a hospital stay, these may have been administered directly by medical staff. To determine if you were exposed to a recalled solution, start by reviewing your medical records, which should include detailed information about the medications, fluids, and solutions administered during your treatment.

You can request these records from the hospital’s medical records department. Alternatively, contacting the hospital directly and asking if they used any recalled products in their procedures or supplies may provide a quicker answer.

Prescribed Solution to Take Home from the Hospital

For those who were prescribed a saline or water solution to use at home after hospital discharge, verifying exposure may involve checking discharge instructions or home-care kits provided by the hospital.

These records often include a list of supplies and medications given to the patient. If you’re unsure of the product details, reach out to the hospital’s pharmacy or patient support services, as they can confirm if any recalled solutions were dispensed for home use and whether you may have been exposed.

Purchased Solution from a Retailer

If you purchased saline or water-based solutions directly from retailers, you can check your purchase history for relevant product details, including the brand, lot numbers, and expiration dates. This information can help determine if the product you bought was part of the recall.

Additionally, if you received any direct notifications from the retailer about a recall, it’s essential to review these notices for specific exposure risks. In cases where records are unavailable, contacting the retailer or the manufacturer can provide clarification on whether your purchased product was included in the recalled batches.

However, a lawyer can assist you in gathering hospital records, medical documentation, and receipts to establish proof of exposure to the recalled solutions.

Examples of Nurse Assist Recall Lawsuits

Stericare Wrongful Death Lawsuit

Babak Sohrabian and Mojgan Homaie filed a SteriCare wrongful death lawsuit on behalf of their deceased son, Kameron Sohrabian, in California Superior Court on November 5, 2024. The defendants named in the lawsuit include Nurse Assist, LLC, Byram Healthcare Centers, Inc., Stericare Solutions, City of Hope, Nicole Karras, M.D., Lisa Gutierrez, N.P., and other unnamed parties.

According to the complaint, Kameron Sohrabian was prescribed four bottles of Nurse Assist 0.9% sodium chloride saline solution, branded as Stericare, to clean open wounds on his legs caused by lymphedema. After using the first bottle, Kameron experienced severe pain and abnormal swelling, which was later diagnosed as a bacterial infection caused by the contaminated saline solution.

On December 12, 2023, Kameron was rushed to the hospital, where he went into septic shock and suffered cardiac arrest, ultimately passing away that same day.

The lawsuit claims that the defendants failed to warn of the bacterial contamination in the saline solution, which led directly to Kameron’s infection, suffering, and death. His parents allege that timely notification of the contamination could have prevented his exposure and tragic outcome. The family now seeks compensation for medical costs, funeral expenses, and the profound emotional and personal loss experienced due to Kameron’s untimely death.

Contact A Nurse Assist Recall Lawsuit

Nurse Assist recall lawyers provide free consultations and claim evaluations for individuals who have suffered injuries caused by the contaminated saline and sterile water products.

To determine whether you or a loved one may be eligible for a Nurse Assist recall lawsuit, submit information about your potential claim for review by a personal injury lawyer to determine whether a settlement or lawsuit payout may be available. There are no fees or expenses unless a recovery is obtained in your case.