Device recall
Z-0015-2011: Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with…
FDA device recall · Class II · Navilyst Medical, Inc
Key facts
| Recall number (Z-number) | Z-0015-2011 |
|---|---|
| Recall event | 56219 |
| Product | Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street… |
| Product code | FGE |
| Recalling firm | Navilyst Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2010 |
| 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