Device recall
Z-1151-2014: Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile…
FDA device recall · Class II · Megadyne Medical Products, Inc.
Key facts
| Recall number (Z-number) | Z-1151-2014 |
|---|---|
| Recall event | 67641 |
| Product | Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during… |
| Product code | GEI |
| Recalling firm | Megadyne Medical Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 9, 2014 |
| 510(k) numbers | K072559 |
| FEI number | 1721194 |
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