FDA-Device2024-04-03Class I
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
DeRoyal Industries Inc
Hazard
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
Sold states
Florida
Affected count
134 tracecarts
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1382-2024Don't want to check this manually?
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