—#206392

Product

GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected lot / code info: a) 53-1831 ORTHO TOTAL JOINT TRACECART, GTIN 0749756598088, Lot Numbers: 57587017 exp 2/1/2024, 57760377 exp 2/1/2024, 58185167 exp 5/1/2024, 58628933 exp 6/1/2024, 58834059 exp 9/1/2024, 58864266 exp 7/1/2024, 59223364 exp 7/1/2024, 59355050 exp 2/1/2025, 59548003 exp 5/1/2025; b) 53-1836 GENERAL SURGERY TRACECART, GTIN 0749756598132, Lot Numbers: 58654875 exp 6/1/2024, 58736096 exp 6/1/2024, 59146688 exp 7/1/2024, 59223356 exp 7/1/2024, 59443367 exp 11/1/2024, 59510136 exp 11/1/2024, 59515455 exp 3/1/2025, 59661866 exp 5/1/2025

Why it was recalled

DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

Root cause (FDA determination)

Other

Action the firm took

DeRoyal Industries notified their sole consignee via email on 02/13/2024. The notice explained the reason for recall, risk, and requested that the affected product Nurse Assist 16F Urine Meter Foley, be removed from the tracecarts and returned. The consignee was instructed to complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory and return the completed form to DeRoyal via fax to 865- 362-3716 or recalls@deroyal.com. For questions regarding credit for the recall, email at recalls@deroyal.com or call 865-362-4203.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Florida

Timeline

Recall initiated: 2024-02-13
Posted by FDA: 2024-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206392. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.