Device recall
Z-0027-2015: BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN…
FDA device recall · Class II · Navilyst Medical, Inc
Key facts
| Recall number (Z-number) | Z-0027-2015 |
|---|---|
| Recall event | 69085 |
| Product | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of… |
| 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