Device recall
Z-0086-2012: O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in…
FDA device recall · Class II · Go Medical Industries Pty., Ltd.
Key facts
| Recall number (Z-number) | Z-0086-2012 |
|---|---|
| Recall event | 59892 |
| Product | O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 8KPES SIZE: 8Fr Product No: AAM 8008KPES***SINGLE USE ONLY***Original design by: Dr. George… |
| Product code | FCM |
| Recalling firm | Go Medical Industries Pty., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 30, 2012 |
| 510(k) numbers | K002803 |
| FEI number | 3002807099 |
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