Medline Sterile Water Solution Recall Issued Due to Infection Risks from Leaking Bottles

Similar problems that led to a different recall last year by Nurse Assist have already resulted in a number of sterile water infection lawsuits by individuals who used those contaminated solutions.

Federal health officials have announced a recall of select Medline medical procedure kits, due to potential leaks in the sterile water and saline solution bottles, specifically where the seal connects to the bottle opening, which raises concerns about potential infection risks for users.

The U.S. Food and Drug Administration (FDA) reported the Medline recall on May 1, indicating that certain Medline sterile water and Medline sterile 0.9% normal saline bottles contained in some of the company’s wound care and laceration trays were leaking.

Wound care trays and laceration trays are sterile medical kits, which are designed for treating wounds and/or lacerations. They often include many of the necessary tools for these procedures, including sutures, scissors, forceps, gauze and other necessities.

Sterile water and sterile saline solutions are often included in these kits, which are supposed to be sealed to provide sterile cleaning tools for wounds and devices used in the treatment of wounds.

However, when a solution’s sterility has been compromised, it may become contaminated with harmful bacteria, which could lead to severe or life-threatening infections in patients who are treated with it.

In the case of the current Medline recall, approximately 5,200 units of sterile water and sterile 0.9% normal saline solution bottles might leak at the point where the peel-foil meets the bottle opening.

The recall affects certain Medline medical procedure kits, which were distributed across the U.S., Panama and Canada, with the following unique device identifiers (UDI) and lot numbers:

• Wound Care Tray, REF DYNDA1412A: UDI/DI 10193489693423 (EA) 40193489693424 (CS), Lot Numbers: 23KBH040
• Laceration Tray, REF DYNDL1263A: UDI/DI 10884389347126 (EA) 40884389347127 (CS), Lot Numbers: 23KBD401

Medline sent an “immediate action required” notice explaining the issue and risks to consignees via both email and U.S. mail on March 19. However, customers who still have the affected products in their possession should immediately destroy them. A credit will be issued upon Medline’s receipt of a completed destruction form.

Customers who have any questions may contact Haley Barclay of Medline at 866-359-1704 or via email at Recalls@Medline.com.

Sterile Water Solution Lawsuits

The Medline recall echoes concerns raised in a Nurse Assist sterile water recall issued in November 2023, which has already resulted in multiple infection lawsuits brought by individuals who used the products to clean wounds. Plaintiffs allege those contaminated Nurse Assist sterile water products caused serious health complications, including infections, sepsis, and, in some cases, death. 

The FDA announced the recall of Nurse Assist sterile water and saline products after that manufacturer discovered that faulty packaging seals could break, compromising the sterile barrier and allowing harmful bacteria to contaminate the solution.

Following the announcement, one of the first Nurse Assist recall lawsuits was filed one year later, alleging that a 26 year old man had developed a severe infection after using contaminated sodium chloride saline solution, which sent him into septic shock and cardiac arrest, ultimately killing him.

Lawyers are continuing to investigate claims related to sterile saline solution recall lawsuits, as infections from from these products could result in a number of serious side effects, injuries or complications, including: