Device recall
Z-1340-2009: Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1340-2009 |
|---|---|
| Recall event | 51334 |
| Product | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION 435428-01 M001273030 FLEXIMA VSCL REG 12FR/35CM M001273040 FLEXIMA VSCL REG 14FR/35CM M001273090 FLEXIMA VSDC REG LOOP 12/35KIT M001273100 FLEXIMA VSDC REG LOOP 14/35KIT M001273150 FLEXIMA VSCL FIRM… |
| Product code | FFA |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 23, 2012 |
| 510(k) numbers | K944290 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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