Device recall
Z-0392-2016: Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0392-2016 |
|---|---|
| Recall event | 72702 |
| Product | Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 Guiding Sheath 6F, 45 cm… |
| Product code | DYB |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 23, 2017 |
| 510(k) numbers | K150186 |
| FEI number | 3002095335 |
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