Drug recall
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer…
FDA recall event 69417 · Class II · Cook Medical Incorporated
Key facts
| Event ID | 69417 |
|---|---|
| Recall numbers | Z-0124-2015 |
| Recalling firm | Cook Medical Incorporated |
| Product type | Devices |
| Products | Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to… |
| Initiation date | Sep 26, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Feb 2, 2016 |
| City | Bloomington |
| State | IN |
| Country | United States |
| FEI number | 3005580113 |
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: