Device recall
Z-1637-2015: Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product…
FDA device recall · Class I · Synovis Surgical Innovations, Inc.
Key facts
| Recall number (Z-number) | Z-1637-2015 |
|---|---|
| Recall event | 71191 |
| Product | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch… |
| Product code | DXZ |
| Recalling firm | Synovis Surgical Innovations, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 18, 2016 |
| 510(k) numbers | K142461 |
| FEI number | 2183620 |
At a glance
- 1–9 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