Device recall
Z-2068-2019: Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units…
FDA device recall · Class II · Epimed International, Inc.
Key facts
| Recall number (Z-number) | Z-2068-2019 |
|---|---|
| Recall event | 83247 |
| Product | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia |
| Product code | BSO |
| Recalling firm | Epimed International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| 510(k) numbers | K023140 |
| FEI number | 1316297 |
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