Drug recall
LIFESTREAM Balloon Expandable Vascular Covered Stent. BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended…
FDA recall event 84173 · Class II · Bard Peripheral Vascular Inc
Key facts
| Event ID | 84173 |
|---|---|
| Recall numbers | Z-0718-2020 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Product type | Devices |
| Products | LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents… |
| Initiation date | Feb 18, 2019 |
| Report date | Dec 25, 2019 |
| Termination date | Apr 28, 2021 |
| 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: