Device recall
Z-0168-2012: SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer…
FDA device recall · Class II · Thomas Medical Products Inc
Key facts
| Recall number (Z-number) | Z-0168-2012 |
|---|---|
| Recall event | 60236 |
| Product | SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M… |
| Product code | DYB |
| Recalling firm | Thomas Medical Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 29, 2012 |
| 510(k) numbers | K003731 |
| FEI number | 3010665433 |
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