Device recall
Z-0661-2010: Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear…
FDA device recall · Class I · Thomas Medical Products Inc
Key facts
| Recall number (Z-number) | Z-0661-2010 |
|---|---|
| Recall event | 54193 |
| Product | Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products… |
| Product code | DYB |
| Recalling firm | Thomas Medical Products Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 1, 2010 |
| 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