Drug recall
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support…
FDA recall event 79896 · Class II · Bard Peripheral Vascular Inc
Key facts
| Event ID | 79896 |
|---|---|
| Recall numbers | Z-1802-2018, Z-1803-2018 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Product type | Devices |
| Products | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature., BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within… |
| Initiation date | Apr 16, 2018 |
| Report date | May 23, 2018 |
| Termination date | Mar 2, 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: