Device recall
Z-0435-2016: AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W)…
FDA device recall · Class II · Summit Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0435-2016 |
|---|---|
| Recall event | 72276 |
| Product | AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity. |
| Product code | LRD |
| Recalling firm | Summit Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2016 |
| FEI number | 3008719017 |
At a glance
- None 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