Device recall
Z-2132-2012: Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic…
FDA device recall · Class II · Baxter Healthcare Renal Div
Key facts
| Recall number (Z-number) | Z-2132-2012 |
|---|---|
| Recall event | 62528 |
| Product | Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler… |
| Product code | FKX |
| Recalling firm | Baxter Healthcare Renal Div |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2012 |
| 510(k) numbers | K923065 |
| FEI number | 3000210122 |
At a glance
- 1–9 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