Device recall
Z-0213-2018: St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl…
FDA device recall · Class I · Sterilmed Inc
Key facts
| Recall number (Z-number) | Z-0213-2018 |
|---|---|
| Recall event | 77470 |
| Product | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when… |
| Product code | DYB |
| Recalling firm | Sterilmed Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 29, 2019 |
| 510(k) numbers | K152090 |
| FEI number | 3011276773 |
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