Device recall
Z-1175-2023: Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41…
FDA device recall · Class II · Covidien, LP
Key facts
| Recall number (Z-number) | Z-1175-2023 |
|---|---|
| Recall event | 91324 |
| Product | Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6 8886… |
| Product code | GAT |
| Recalling firm | Covidien, LP |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K990952 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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