Device recall
Z-0158-2014: Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia…
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0158-2014 |
|---|---|
| Recall event | 66351 |
| Product | Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional… |
| Product code | CAZ |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2016 |
| FEI number | 1217052 |
At a glance
- None 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