Device recall
Z-1027-2019: Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box…
FDA device recall · Class II · CP Medical Inc
Key facts
| Recall number (Z-number) | Z-1027-2019 |
|---|---|
| Recall event | 82197 |
| Product | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues. |
| Product code | GAL |
| Recalling firm | CP Medical Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K001299 |
| FEI number | 3012164473 |
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