Device recall
Z-0160-2016: BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are…
FDA device recall · Class II · LifeHealth, LLC
Key facts
| Recall number (Z-number) | Z-0160-2016 |
|---|---|
| Recall event | 72305 |
| Product | BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System. |
| Product code | CHL |
| Recalling firm | LifeHealth, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2016 |
| 510(k) numbers | 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