PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: April 3, 2024 Initiated: February 13, 2024 #Z-1382-2024

Product Description

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

Reason for Recall

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

Details

Recalling Firm
DeRoyal Industries Inc
Units Affected
134 tracecarts
Distribution
Florida
Location
Powell, TN

Frequently Asked Questions

What product was recalled?
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART. Recalled by DeRoyal Industries Inc. Units affected: 134 tracecarts.
Why was this product recalled?
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 3, 2024. Severity: Critical. Recall number: Z-1382-2024.