Device recall
Z-1381-05: Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting…
FDA device recall · Class III · International Technidyne Corp.
Key facts
| Recall number (Z-number) | Z-1381-05 |
|---|---|
| Recall event | 31937 |
| Product | Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820. |
| Product code | JBP |
| Recalling firm | International Technidyne Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 25, 2005 |
| 510(k) numbers | K960749 |
| FEI number | 1000526865 |
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