Drug recall
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for…
FDA recall event 63642 · Class II · OmniGuide, Inc.
Key facts
| Event ID | 63642 |
|---|---|
| Recall numbers | Z-0453-2013 |
| Recalling firm | OmniGuide, Inc. |
| Product type | Devices |
| Products | OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient |
| Initiation date | Nov 5, 2012 |
| Report date | Dec 12, 2012 |
| Termination date | Oct 16, 2014 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3005350457 |
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: