Drug recall
Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2…
FDA recall event 81594 · Class II · Arcos, Inc
Key facts
| Event ID | 81594 |
|---|---|
| Recall numbers | Z-2295-2019 |
| Recalling firm | Arcos, Inc |
| Product type | Devices |
| Products | Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Battery packs may heat up abnormally and ignite in rare instance. |
| Initiation date | Mar 16, 2015 |
| Report date | Aug 28, 2019 |
| Termination date | Feb 9, 2022 |
| City | Missouri City |
| State | TX |
| Country | United States |
| FEI number | 3010283477 |
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: