Device recall
Z-0647-2012: Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with…
FDA device recall · Class II · Navilyst Medical, Inc
Key facts
| Recall number (Z-number) | Z-0647-2012 |
|---|---|
| Recall event | 60775 |
| Product | Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd. Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical… |
| Product code | FGE |
| Recalling firm | Navilyst Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2012 |
| 510(k) numbers | K093392 |
| FEI number | 3017892510 |
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