Device recall
Z-0188-2012: PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads…
FDA device recall · Class II · Alere San Diego
Key facts
| Recall number (Z-number) | Z-0188-2012 |
|---|---|
| Recall event | 60370 |
| Product | PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio… |
| Product code | LKB |
| Recalling firm | Alere San Diego |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 29, 2012 |
| 510(k) numbers | K020679, K021923, K072727 |
| FEI number | 1000125596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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