Device recall
Z-0439-2009: SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by…
FDA device recall · Class II · Rockwell Medical Technologies, Inc
Key facts
| Recall number (Z-number) | Z-0439-2009 |
|---|---|
| Recall event | 49580 |
| Product | SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis)… |
| Product code | KPO |
| Recalling firm | Rockwell Medical Technologies, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 29, 2010 |
| 510(k) numbers | K022521 |
| FEI number | 3003463852 |
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