Device recall
Z-1784-2013: HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is…
FDA device recall · Class II · Instrumentation Laboratory Co.
Key facts
| Recall number (Z-number) | Z-1784-2013 |
|---|---|
| Recall event | 65399 |
| Product | HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy. |
| Product code | GJS |
| Recalling firm | Instrumentation Laboratory Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2015 |
| 510(k) numbers | K070005 |
| FEI number | 1217183 |
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