Source: US Food and Drug Administration
Please be aware, this recall is a correction, not a product removal.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names: Regard Operative Lap P&S Surgical Kit
- Product Codes: LRO – See Recall Database Entry
- Model Numbers: 800943001
- Distribution Dates: January 12, 2022 to July 10, 2023
- Devices Recalled in the U.S.: 345
- Date Initiated by Firm: December 18, 2023
The Regard Operative Lap P&S Surgical Kit is a single-use, surgical kit, containing surgical tools and materials for various surgical procedures in different medical areas.
Reason for Recall
ROi CPS, LLC is recalling their Regard Operative Lap P&S Surgical Kit due to the possibility they may not be sterile. The surgical kits were built with a recalled item from a separate Class I recall from Nurse Assist. Nurse Assist, LLC recalled their 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to the potential for a lack of sterility. In populations most at risk, such as patients who have a weakened immune system, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.
There have been zero reports of injury or death.
Who May be Affected
- Health care providers using Regard Operative Lap P&S Surgical trays or kits
- People who receive care using Regard Operative Lap P&S Surgical trays or kits
What to Do
On December 18, 2023, Roi CPS, LLC sent all affected customers an Important Medical Device Advisory.
The letter requested customers to:
- Check inventory and determine if any of the affected items are included in the user’s inventory.
- Isolate and quarantine all affected kits in the user’s inventory.
- Print out the included warning labels and attach to all affected kits in the user’s inventory.
- Complete the included reply form and return to ROi CPS, LLC.
- Notify any customers who have been distributed or forwarded affected products.
- Report any adverse health consequences to the FDA’s MedWatch Adverse Event Reporting program.
Customers in the U.S. with questions about this recall should contact Lee Creviston from Roi CPS, LLC at 615-344-3956.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.