Regard Operative Lap P&S Surgical Kits made by ROi CPS pose a risk of serious harm due to the possibility that some kits may not be sterile, the FDA said in a Jan. 16 notice.
The single-use surgical kits were built with a previously recalled product, 0.9% sodium chloride irrigation USP and sterile water for irrigation USP from Nurse Assist, which was recalled over potential sterility issues.
"In populations most at risk, such as patients who have a weakened immune system, there is a possibility that use of the affected product could potentially result in severe or life-threatening adverse events," the FDA said, adding there have been no reports of injury or death.
ROi CPS alerted customers about the 345 affected surgical kits in December. The products were distributed between Jan. 12, 2022, and July 10, 2023.
The FDA issued a Class I recall for the product, but the agency clarified it as a warning and not a product removal.