Device recall
Z-1253-06: Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a…
FDA device recall · Class III · Baxter Healthcare Renal Div
Key facts
| Recall number (Z-number) | Z-1253-06 |
|---|---|
| Recall event | 35706 |
| Product | Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter''s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis Instruments; Baxter Healthcare Corporation, Deerfield, IL 60015; item numbers 6001276024 and 6001276028 |
| Product code | KDI |
| Recalling firm | Baxter Healthcare Renal Div |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 4, 2008 |
| 510(k) numbers | K030099, K970446 |
| FEI number | 3000210122 |
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