The FDA is recalling additional saline and sterile water products made by Nurse Assist after receiving reports of adverse events.
On Nov. 6, Nurse Assist, a Texas manufacturer of water-based medical products, voluntarily recalled some products that were found to not be sterile. At the time, no adverse events were associated with the affected products.
However, a Feb. 13 FDA update said the agency has received reports of adverse events associated with Nurse Assist products. The events are under investigation and no details were provided.
The affected products were distributed in the U.S. and Canada between November 2021 and mid-September 2023. Twelve Nurse Assist brand products are part of the recall including sterile saline bottles, prefilled and IV flush syringes, and USP sterile water syringes.
In addition, sterile water and saline products under brand names Stericare, Cardinal, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol and Trudell are also part of the recall.
In January, three companies voluntarily recalled products of their own that contained Nurse Assist water-solutions:
- Maquet Cardiovascular recalled its Atrium Express Dry Suction Dry Seal Chest Drain
- ROi CPS recalled its operative lap P&S surgical kit.
- Busse Hospital Disposables recalled its care trays and kits.