Drug recall
Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP…
FDA recall event 79425 · Class II · Cook Vascular Inc.
Key facts
| Event ID | 79425 |
|---|---|
| Recall numbers | Z-1223-2018 |
| Recalling firm | Cook Vascular Inc. |
| Product type | Devices |
| Products | Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is… |
| Initiation date | Nov 28, 2017 |
| Report date | Apr 4, 2018 |
| Termination date | Oct 3, 2018 |
| City | Vandergrift |
| State | PA |
| Country | United States |
| FEI number | 2522007 |
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: