Device recall
Z-1988-2013: Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex…
FDA device recall · Class II · Aspen Surgical Products, Inc.
Key facts
| Recall number (Z-number) | Z-1988-2013 |
|---|---|
| Recall event | 65745 |
| Product | Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips… |
| Product code | FPX |
| Recalling firm | Aspen Surgical Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2014 |
| 510(k) numbers | K874813 |
| FEI number | 3002750084 |
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