Device recall
Z-0563-2015: Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage…
FDA device recall · Class II · Pfm Medical Inc
Key facts
| Recall number (Z-number) | Z-0563-2015 |
|---|---|
| Recall event | 69666 |
| Product | Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous… |
| Product code | LJS |
| Recalling firm | Pfm Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2015 |
| 510(k) numbers | K083873 |
| FEI number | 3013666218 |
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