Device recall
Z-0262-2012: PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They…
FDA device recall · Class II · Del Mar Reynolds Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-0262-2012 |
|---|---|
| Recall event | 60205 |
| Product | PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . Hook-up kits that contain the affected alcohol prep pads are as follows: Aria, Kit Part number 23189-010… |
| Product code | KOY |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 23, 2012 |
| FEI number | 3002807992 |
At a glance
- None 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