DeRoyal Industries, Inc. recalls Tracecarts under recall by Nurse Assist

Urgent Class I Recall Notice  

DeRoyal Industries, Inc. has issued an urgent recall notice for certain Tracecarts containing 16FR Urine Meter Foley under recall by Nurse Assist. Identified by the FDA as a Class I recall, the most serious type, the use of these devices may pose significant risks, including serious injuries or even death. 

Recalled Product Details: 

• Product Names: GeoMed Custom Tracecarts 
• Product Codes: LRO 
• Model Numbers: 

• • 53-1829 Laminectomy Tracecart 
  • 53-1831 Ortho Total Joint Tracecart 
  • 53-1836 General Surgery Tracecart 

• Distribution Dates: August 25, 2022, to September 26, 2023 
• Devices Recalled in the U.S.: 134 
• Date Initiated by Firm: February 14, 2024 

Device Use

The DeRoyal Tracecart is a general surgery tray. It aids clinicians in maintaining a sterile field, preventing contamination, and organizing surgical instruments and supplies during procedures. Included in this recall are kits such as the Laminectomy, Ortho Total Joint, and General Surgery Tracecarts. The 16FR Urine Meter Foley, a urinary catheter with a meter for measuring urine output, is one of the components found in these kits. 

Reason for Recall

DeRoyal is recalling specific Surgical Tracecarts containing the Nurse Assist 16FR Silver Urine Meter Foley due to Nurse Assist LLC’s recall on November 6, 2023, citing sterility concerns. While other items within the Tracecarts remain unaffected, the use of the affected trays may lead to serious adverse health consequences. 

Who May be Affected

• Health care providers utilizing DeRoyal Tracecarts 

• Individuals receiving care using DeRoyal Tracecarts 

Recommended Actions

Affected customers received an Urgent Recall Notice from DeRoyal Industries, Inc. on February 13, 2024. The notice requests the following actions: 

• Identify affected surgical packs using the provided Affected Products Listing and quarantine them to prevent further use. 
• Return any Nurse Assist 16FR Urine Meter Foley units to DeRoyal for appropriate handling. 
• Complete the provided NOTICE OF RETURN FORM, specifying all affected products. 
• Inform all locations where these products have been distributed about the recall and advise them accordingly. 

Contact Information

For customers in the U.S. with inquiries regarding this recall, DeRoyal Industries, Inc. can be reached at 865-362-4203. 

It is crucial for healthcare providers and individuals using these products to adhere to the recall notice to ensure patient safety and prevent any potential risks associated with the use of the affected devices. 

Links 

Read the FDA recall announcement here.