Device recall
Z-0800-06: Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to…
FDA device recall · Class II · Smiths Medical MD, Inc.
Key facts
| Recall number (Z-number) | Z-0800-06 |
|---|---|
| Recall event | 35148 |
| Product | Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4653-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque… |
| Product code | MMP |
| Recalling firm | Smiths Medical MD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2007 |
| 510(k) numbers | K871132, K931073 |
| FEI number | 2183502 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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