Device recall
Z-0533-2018: 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane…
FDA device recall · Class II · Medical Components, Inc dba MedComp
Key facts
| Recall number (Z-number) | Z-0533-2018 |
|---|---|
| Recall event | 78221 |
| Product | 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 access to the vascular system. The port system can be used for infusion of medications, I.V. fluids… |
| Product code | LJT |
| Recalling firm | Medical Components, Inc dba MedComp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2018 |
| 510(k) numbers | K132177 |
| FEI number | 2518902 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database