FDA Issues Warning on ROi CPS Surgical Kits Due to Potential Sterility Issues

Regard Operative Lap P&S Surgical Kits, manufactured by ROi CPS, have been flagged by the U.S. Food and Drug Administration (FDA) for potential sterility issues. The FDA has issued a Class I recall for the product, characterizing it as a warning and not a product removal. The surgical kits were made with a previously recalled product, namely, 0.9% sodium chloride irrigation USP and sterile water for irrigation USP from Nurse Assist, thereby posing a risk of serious harm.

Risk of Severe or Life-threatening Adverse Events

The FDA has stated that the use of the affected product could potentially result in severe or life-threatening adverse events, especially in populations most at risk, such as patients with weakened immune systems. This warning from the FDA is of utmost significance as it highlights the potential risk of using non-sterile surgical kits on vulnerable patients. It is strongly recommended that health care providers take note of this warning and ensure that the surgical kits they use are not affected.

ROi CPS Responds to the Warning

In response to the FDA's warning, ROi CPS alerted its customers about the affected surgical kits. The company has taken proactive measures to ensure that the information reaches all its customers. The affected products were distributed between January 12, 2022, and July 10, 2023. This substantial time period indicates that the number of potentially affected kits could be significant.

Recall Classifications and What They Mean

The FDA’s recall classification of Class I is reserved for situations where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. In this particular case, the FDA has clarified that it is issuing a warning and not demanding a product removal. This means that while the risk is acknowledged, no incidents of injury or death have been reported related to the affected kits till date.

Staying Informed About Medical Device Safety

The FDA provides a range of resources for staying informed about medical device safety. This includes the FDA’s official website which offers CDRH updates, including ASCA-Accredited Testing Laboratories. Users can subscribe to receive daily CDRH email updates. Additionally, information on recent safety communications, letters to health care providers, and medical device recalls can also be found on the FDA website.

The FDA's MedWatch program is another excellent resource. This safety reporting program is designed for health professionals, patients, and consumers. It receives reports from the public and publishes safety alerts for FDA-regulated products, providing a gateway for clinically important safety information and reporting serious problems with regulated products.

As health care providers and consumers, it is crucial to stay informed about the medical devices we use. With resources like the FDA's official website and the MedWatch program, we can ensure that we have access to the most up-to-date safety information.