Device recall
Z-1519-2011: Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL…
FDA device recall · Class II · Fisher Diagnostics, A Company of Fisher Scientific LLC
Key facts
| Recall number (Z-number) | Z-1519-2011 |
|---|---|
| Recall event | 57107 |
| Product | Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA*** Thromboplastin-DS is a Class 2 medical device intended for use… |
| Product code | GJS |
| Recalling firm | Fisher Diagnostics, A Company of Fisher Scientific LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2011 |
| 510(k) numbers | K940082 |
| FEI number | 1181121 |
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