Device recall
Z-0031-2015: PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve…
FDA device recall · Class II · Navilyst Medical, Inc
Key facts
| Recall number (Z-number) | Z-0031-2015 |
|---|---|
| Recall event | 69085 |
| Product | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 |
| Product code | LJS |
| Recalling firm | Navilyst Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2017 |
| 510(k) numbers | K042061 |
| FEI number | 3017892510 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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