Device recall
Z-0090-2019: Reprocessed Agilis Steerable Introducer: indicated for introducing various…
FDA device recall · Class II · Sterilmed, Inc.
Key facts
| Recall number (Z-number) | Z-0090-2019 |
|---|---|
| Recall event | 80999 |
| Product | Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71… |
| Product code | PNH |
| Recalling firm | Sterilmed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2020 |
| 510(k) numbers | K152090 |
| FEI number | 3011276773 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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