Drug recall
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition…
FDA recall event 87316 · Class II · Bard Peripheral Vascular Inc
Key facts
| Event ID | 87316 |
|---|---|
| Recall numbers | Z-1289-2021 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Product type | Devices |
| Products | BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use. |
| Initiation date | Jan 14, 2021 |
| Report date | Mar 31, 2021 |
| Termination date | Jan 28, 2025 |
| City | Tempe |
| State | AZ |
| Country | United States |
| FEI number | 2020394 |
At a glance
- 1–9 Products in this recall
- 10–99 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: