Device recall
Z-1907-2008: Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-1907-2008 |
|---|---|
| Recall event | 47828 |
| Product | Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use. The device is indicated for use in sampling blood for oxygen levels and measuring pressure in the… |
| Product code | LDF |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2009 |
| 510(k) numbers | K960479 |
| FEI number | 1036844 |
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