The FDA is warning healthcare providers and consumers about a December 18, 2023 recall of Regard Operative Lap P&S Surgical Kit by ROi CPS, LLC because the product may not be sterile. Officials have since identified the corrective recall as Class I, the most serious type, because use of the kit was determined to put individuals at risk of “serious injuries or death.”
A surgical kit designed for single use, the Regard Operative P&S Surgical Kit is comprised of “surgical tools and materials for various surgical procedures in different medical areas.”
The recall affects 345 kits under model number 800943001 that were distributed between January 12, 2022 and July 10, 2023.
ROi CPS, LLC first took action after learning that the surgical kits were created with an item from a different Class I recall from Nurse Assist. On December 19, 2023, both the 0.9% sodium chloride irrigation USP and the sterile water for irrigation USP were recalled by Nurse Assist, LLC because the products’ sterility was called into question.
The potential lack of sterility in those components was determined to pose a risk to patients with weakened immune systems, who could suffer major or life-threatening outcomes if they use an affected product.
While the company has not received any reports of related injury or death to date, healthcare professionals who use the Regard Operative Lap P&S Surgical trays or kits, as well as the patients who receive care with the kits, are advised that they could be adversely impacted.
An Important Medical Device Advisory issued by ROi CPS, LLC on December 18, 2023 requested that all customers:
- Evaluate their inventory for any affected items
- Quarantine any affected items found in the inventory
- Upload and print warning labels in order to attach them to all impacted kits in the inventory
- Complete the reply form attached to the Medical Device Advisory and submit it to ROi CPS, LLC.
- Alert any customers who may have been distributed or forwarded the impacted items.
- Be alert to any adverse health outcomes that may be related to the issue and report them to the FDA’s MedWatch Adverse Event Reporting program.
Recall-related questions may be directed to ROi CPS, LLC representative Lee Creviston at 615-344-3956.
Have you or a loved one experienced an adverse health outcome that can be traced to the use of a compromised medical device? Our compassionate attorneys at TruLaw work tirelessly to help people in your situation pursue maximum compensation and hold negligent parties responsible for pain and suffering. To learn about how we can work together, connect with us online or try out our free Instant Case Evaluation ℠.