Device recall
Z-0635-2014: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety…
FDA device recall · Class II · Ansell Sandel Medical Industries LLC
Key facts
| Recall number (Z-number) | Z-0635-2014 |
|---|---|
| Recall event | 67005 |
| Product | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell… |
| Product code | GDZ |
| Recalling firm | Ansell Sandel Medical Industries LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 6, 2016 |
| FEI number | 3004125670 |
At a glance
- None Linked 510(k)s
- 1–9 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