Device recall
Z-1627-2014: LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral…
FDA device recall · Class II · Hospira Inc.
Key facts
| Recall number (Z-number) | Z-1627-2014 |
|---|---|
| Recall event | 68129 |
| Product | LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures |
| Product code | GBX |
| Recalling firm | Hospira Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 6, 2016 |
| 510(k) numbers | K841362 |
| FEI number | 3013319212 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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