Drug recall
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an…
FDA recall event 70457 · Class II · Medical Components, Inc dba MedComp
Key facts
| Event ID | 70457 |
|---|---|
| Recall numbers | Z-1527-2015 |
| Recalling firm | Medical Components, Inc dba MedComp |
| Product type | Devices |
| Products | 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The dual port with catheters was not covered under FDA clearance. |
| Initiation date | Jan 28, 2015 |
| Report date | May 6, 2015 |
| Termination date | Jan 6, 2017 |
| City | Harleysville |
| State | PA |
| Country | United States |
| FEI number | 2518902 |
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: