Device recall
Z-1350-2008: Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials…
FDA device recall · Class III · Wescor, Inc
Key facts
| Recall number (Z-number) | Z-1350-2008 |
|---|---|
| Recall event | 46214 |
| Product | Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321. |
| Product code | JJM |
| Recalling firm | Wescor, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 27, 2008 |
| 510(k) numbers | K834208 |
| FEI number | 1717966 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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