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Open, Classified

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

FDA Recall Z-1382-2024 · Posted 2024-03-29

Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2024-02-13
Product Quantity134 tracecarts

Reason for Recall

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

Firm Action

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 [email protected]. For questions regarding credit for the recall, email at [email protected] or call 865-362-4203.

Root Cause

Other

Distribution Pattern

Florida

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842648GENERAL SURGERY TRAYDeroyal Industries, Inc. · 1984-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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