Device recall
Z-1072-03: IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge…
FDA device recall · Class III · Diametrics Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1072-03 |
|---|---|
| Recall event | 26714 |
| Product | IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A). |
| Product code | JJE |
| Recalling firm | Diametrics Medical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 2, 2004 |
| 510(k) numbers | K924758, K945240 |
| FEI number | 1000115726 |
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