DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist
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.
Recalled Product
- 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 that includes surgical drape and drape accessories used during surgical procedures to maintain a sterile field, provide a barrier against contamination, and aid in the organization of surgical instruments and supplies. The kits in this recall include the Laminectomy, Ortho Total Joint, and General Surgery Tracecarts.
The 16FR Urine Meter Foley mentioned in the kits is a urinary catheter with a meter for measuring urine output, commonly used in surgical and medical settings to manage urinary retention or monitor urinary output during procedures.
Reason for Recall
DeRoyal is recalling certain Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley. The Nurse Assist 16FR Urine Meter Foley is one of the items found within the firm's Tracecarts. This recall is in direct response to Nurse Assist LLC's, November 6, 2023, recall over sterility concerns. The rest of the items contained in the tracecart are not affected or impacted by this recall.
The use of the affected trays may cause serious adverse health consequences.
There have been no reported injuries and no reports of death.
Who May be Affected
- Health care providers using DeRoyal Tracecarts
- People who receive care using DeRoyal Tracecarts
What to Do
On February 13, 2024, DeRoyal Industries, Inc. sent all affected customers an Urgent Recall Notice.
The letter requested customers to:
- Utilize the included Affected Products Listing to identify affected surgical packs and place them in quarantine 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, indicating all affected products.
- Inform all locations where these products have been distributed about the recall and advise them accordingly.
Contact Information
Customers in the U.S. with questions about this recall should contact DeRoyal Industries, Inc. at 865-362-4203.
Additional Resources
- Class 1 Device Recall GeoMed (fda.gov)
- Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication
- Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada
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.