Device recall
Z-1351-2015: Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen…
FDA device recall · Class II · Medical Components, Inc dba MedComp
Key facts
| Recall number (Z-number) | Z-1351-2015 |
|---|---|
| Recall event | 70472 |
| Product | Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and… |
| Product code | MSD |
| Recalling firm | Medical Components, Inc dba MedComp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2015 |
| 510(k) numbers | K030502, K111651, K994105 |
| 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