Device recall
Z-1881-2010: Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane…
FDA device recall · Class I · Navilyst Medical, Inc
Key facts
| Recall number (Z-number) | Z-1881-2010 |
|---|---|
| Recall event | 55786 |
| Product | Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN Product No. M001453030, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by… |
| Product code | LJT |
| Recalling firm | Navilyst Medical, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 3, 2012 |
| 510(k) numbers | K903364, K942623, K945250, K954258 |
| 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