Device recall
Z-0190-2012: Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic…
FDA device recall · Class III · Isopure Corp
Key facts
| Recall number (Z-number) | Z-0190-2012 |
|---|---|
| Recall event | 60366 |
| Product | Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Step |
| Product code | KPO |
| Recalling firm | Isopure Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 24, 2012 |
| 510(k) numbers | K041163 |
| FEI number | 3013942511 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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