Device recall
Z-0261-05: AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract…
FDA device recall · Class II · Trinity Biotech USA
Key facts
| Recall number (Z-number) | Z-0261-05 |
|---|---|
| Recall event | 30354 |
| Product | AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, IDA Business Park, Bray, County Wicklow, Ireland. USA Enquiries - Trinity Biotech USA, 1930 Innerbelt… |
| Product code | GJS |
| Recalling firm | Trinity Biotech USA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2005 |
| 510(k) numbers | K972796 |
| FEI number | 1318354 |
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