FDA Expands Recall of Saline and Sterile Water Products By Nurse Assist
The U.S. Food and Drug Administration (FDA) has announced that Nurse Assist, LLC initiated a voluntary recall of various saline (0.9% sodium chloride) and sterile water products on January 12th, 2023. The recall came after the company received several reports indicating that some products may not be sterile. This poses infection risks to patients if the products are used.
On March 12, 2024, the FDA updated the recall to add, an additional related recall of saline and sterile water medical products associated with Nures Assist. According to the FDA website, “The FDA is receiving reports of adverse events associated with use of Nurse Assist products and is further evaluating this information.”
The initial recall impacted saline flush syringes, saline vials, and sterile water sold under the Nurse Assist brand. It also included products made by Nurse Assist but labeled under other major brands like Cardinal Health, Covidien, Halyard, and Medline. The recall covered over 2 million saline flush syringes, thousands of saline vials, and over half a million units of sterile water.
Expanded Recall Announced
The FDA announced an expanded recall to include more production lots of saline and sterile water products made by Nurse Assist. This came as the agency’s ongoing investigation revealed additional products that may be affected. The expanded recall now includes certain lots of:
- Nurse Assist Saline Flush Syringes
- Nurse Assist Saline Vials
- Nurse Assist Sterile Water Vials
- Cardinal Health Saline Flush Syringes
- Medline Saline Flush Syringes
The additional recalled lots were distributed nationwide to healthcare facilities between October 2022 and January 2023.
See the full list of recalled lots here.
According to the FDA safety communication, the initial recall was prompted by the agency’s recent inspection of the Nurse Assist manufacturing facility.
This highlights the critical importance of ongoing compliance and quality monitoring for companies that manufacture sterile drug products.
The FDA has advised healthcare facilities and providers to immediately stop using any saline flush syringes, saline vials, or sterile water products impacted by the recall. They recommend confirming the sterility of any remaining inventory by checking lot numbers.
If facilities have any of the recalled products, they should contact the manufacturer for further instructions and replacement products where appropriate. The agency emphasizes that using contaminated products on patients could lead to dangerous infections requiring antibiotic treatment or hospitalization.
This recall remains ongoing as the FDA continues its investigation alongside the manufacturer. Additional updates will be provided as more details emerge.
