Device recall
Z-0223-2018: Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021)…
FDA device recall · Class II · Terumo Medical Corp
Key facts
| Recall number (Z-number) | Z-0223-2018 |
|---|---|
| Recall event | 77661 |
| Product | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY |
| Product code | DYB |
| Recalling firm | Terumo Medical Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2019 |
| 510(k) numbers | K142183 |
| FEI number | 2243441 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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