Device recall
Z-0033-2012: Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380…
FDA device recall · Class III · Isopure Corp
Key facts
| Recall number (Z-number) | Z-0033-2012 |
|---|---|
| Recall event | 59879 |
| Product | Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and… |
| Product code | FJP |
| Recalling firm | Isopure Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 19, 2013 |
| 510(k) numbers | K993272 |
| FEI number | 3013942511 |
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