Drug recall
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog #…
FDA recall event 78221 · Class II · Medical Components, Inc dba MedComp
Key facts
| Event ID | 78221 |
|---|---|
| Recall numbers | Z-0533-2018 |
| Recalling firm | Medical Components, Inc dba MedComp |
| Product type | Devices |
| Products | 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip. |
| Initiation date | May 25, 2017 |
| Report date | Feb 14, 2018 |
| Termination date | Sep 4, 2018 |
| 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: