FDA recall Z-1382-2024

DeRoyal Industries Inc · Class I · device

Product

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.

Distribution

Florida

Key facts

Status
Ongoing
Initiation date
2024-02-13
Report date
2024-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1382-2024