SteriCare Lawsuit: Contaminated Sterile Water & Saline Solutions

SteriCare products are sterile saline and water solutions used for medical irrigation. These products may be used for:

• Cleaning wounds
• Flushing out medical tubing, such as catheters
• Rinsing body cavities

Nurse Assist, LLC is a leading manufacturer of these products. They sell the products directly under both the Nurse Assist and SteriCare Solutions brands. SteriCare products may also be sold by other manufacturers or distributors under their own labels. Companies that have sold SteriCare saline products include:

• Atrium
• Cardinal Health
• Covidien
• Halyard Owens Minor
• McKesson
• Medline

People are filing SteriCare lawsuits because the company’s sterile products may have been contaminated. They claim the contamination increased the risk of serious or life-threatening infections.

In November 2023, Nurse Assist, LLC voluntarily recalled some of its Stericare products. The company found that some packaging may have compromised sterile barriers. The weakened barriers potentially allowed harmful bacteria to enter some products. The products in question had been distributed in the U.S. and Canada from November 2021 through September 2023.

The U.S. Food and Drug Administration (FDA) has labeled this as a Class I recall. Class I recalls are considered their most serious recalls, as they pose the risk of serious injuries or death. To get a full list of the recalled products, visit the FDA SteriCare recall notice page. The list includes brand names, product numbers, volumes and type of product (bottles vs syringes).

What harms are alleged in SteriCare lawsuits?

Using a contaminated irrigation product could potentially cause a serious or life-threatening infection. Potential infection areas include:

• Bloodstream
• Open wound
• Respiratory
• Soft tissue
• Urinary tract

These infections may be dangerous for any person, but risks increase for some people. People in this group include:

• Cancer patients
• Critically ill
• Elderly
• Immunocompromised
• Pregnant
• Suffering from chronic diseases

The company reported that it had not heard of any adverse events at the time of the November 2023 recall. However, the FDA reports it is investigating claims of adverse events it received after the recall was announced. As of October 2024, approximately 120 adverse events were reported to the FDA Manufacturer and User Facility Experience Database. 

Anyone who has suffered an infection that can be linked to using a SteriCare product may be eligible to file a personal injury lawsuit. People may also be able to file a lawsuit on behalf of a loved one, particularly if they passed away from their injuries. Some ways to know if you’re eligible include:

• You were injured after November 2021, used a saline product to clean your wound and developed a serious infection
• You received surgery after November 2021 and developed a serious infection

If you’re unsure if you used a potentially contaminated product, a medical drug, device and product attorney at Motley Rice may be able to help. Our attorneys have experience investigating similar claims relating to allegedly defective products.

If you believe you may have a claim, it’s important to reach out soon. Be sure to file your claim before the statute of limitations expires. If you file after it expires, you may not be eligible to seek justice for your injuries.

What SteriCare products were recalled?

According to the FDA, the following SteriCare products were voluntarily recalled in November 2023: 

Is this the first recall of SteriCare products?

The November 2023 recall is the second recall of SteriCare products for potential contamination. In October 2016, Nurse Assist, LLC recalled its prefilled saline IV flush syringes. In that recall, the products were linked to outbreaks of severe infections in several states.

Who do you sue in a SteriCare lawsuit?

If you or a loved one developed a bacterial infection after using a SteriCare product that was recalled, you may be able to sue Nurse Assist, LLC, the primary manufacturer of the compromised sterile saline product. You may also be able to name distributors, like McKesson, in the suit depending on the circumstances of your case.

What damages may you be eligible for in a SteriCare lawsuit?

While the damages you may be eligible for will depend on the circumstances of your claim, potential damages for a SteriCare lawsuit could include:

• Economic damages: Medical bills, lost wages
• Non-economic damages: Pain and suffering, loss of consortium

Speaking with a SteriCare lawyer can help you understand what damages you may file a claim for.

Our medical attorneys have experience representing many clients impacted by allegedly defective medical devices, drugs and other medical products. Our law firm’s previous litigation experience includes representing clients harmed by:

• Artificial Tears
• Breast implants
• CooperSurgical IVF treatments
• Duodenoscopes/Endoscopes
• Hernia mesh
• Surgical staplers

Learn more about our medical device litigation experience here.