Recall Z-1382-2024— DeRoyal Industries Inc

Name: FDA recall Z-1382-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-13

Class I · Ongoing

Class I FDA medical device recall by DeRoyal Industries Inc, initiated 2024-02-13. It names one FDA 510(k) clearance: K842648. Product: GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART. Reason: DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled..

Recalling firm: DeRoyal Industries Inc
Classification: Class I
Status: Ongoing
Initiated: 2024-02-13
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K842648 — GENERAL SURGERY TRAYDeroyal Industries, Inc.·cleared 1984-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.