Device recall
Z-0135-2012: AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label…
FDA device recall · Class II · Sierra Scientific Instruments Inc
Key facts
| Recall number (Z-number) | Z-0135-2012 |
|---|---|
| Recall event | 60175 |
| Product | AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a… |
| Product code | FFX |
| Recalling firm | Sierra Scientific Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 2012 |
| 510(k) numbers | K031169 |
| FEI number | 3005344223 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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