Drug recall
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products…
FDA recall event 74637 · Class II · BEST THERATRONICS LTD.
Key facts
| Event ID | 74637 |
|---|---|
| Recall numbers | Z-2251-2016 |
| Recalling firm | BEST THERATRONICS LTD. |
| Product type | Devices |
| Products | Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| Reason for recall | It was discovered that both the new device and the predicate device failed to comply with performance standard. |
| Initiation date | May 6, 2016 |
| Report date | Aug 3, 2016 |
| Termination date | Aug 1, 2017 |
| City | KANATA |
| Country | Canada |
| FEI number | 3006946288 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: