Device recall
Z-0444-2019: Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5…
FDA device recall · Class II · Espiner Medical Ltd
Key facts
| Recall number (Z-number) | Z-0444-2019 |
|---|---|
| Recall event | 81003 |
| Product | Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be… |
| Product code | GCJ |
| Recalling firm | Espiner Medical Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2019 |
| 510(k) numbers | K111845 |
| FEI number | 3009231402 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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