Drug recall
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY…
FDA recall event 94129 · Class I · DeRoyal Industries Inc
Key facts
| Event ID | 94129 |
|---|---|
| Recall numbers | Z-1382-2024 |
| Recalling firm | DeRoyal Industries Inc |
| Product type | Devices |
| Products | GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. |
| Initiation date | Feb 13, 2024 |
| Report date | Apr 3, 2024 |
| City | Powell |
| State | TN |
| Country | United States |
| FEI number | 1043214 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: