Drug recall
TropoCells Autologous Platelet Preparation Kit PRP- Platelet preparation tube (PPT-1) 22 ml tube, Catalog #…
FDA recall event 89726 · Class I · Estar Technologies Ltd.
Key facts
| Event ID | 89726 |
|---|---|
| Recall numbers | B-0293-2022 |
| Recalling firm | Estar Technologies Ltd. |
| Product type | Biologics |
| Products | TropoCells Autologous Platelet Preparation Kit PRP- Platelet preparation tube (PPT-1) 22 ml tube, Catalog # 14532205GLVAS and 11 ml tubes (ref# 12531102GLVAS) TropoCells Autologous Platelet… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | TropoCells Autologous Platelet Preparation Kit PRP- Platelet preparation tube (PPT-1) 22 ml tubes, with higher than normal endotoxin levels, were distributed.. |
| Initiation date | Mar 1, 2022 |
| Report date | Mar 30, 2022 |
| Termination date | Mar 14, 2023 |
| City | Holon |
| Country | Israel |
| FEI number | 3002047500 |
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: