Drug recall
Amniotic membrane
FDA recall event 65189 · Class II, Class III · TissueTech, Inc. dba Bio-Tissue, Inc.
Key facts
| Event ID | 65189 |
|---|---|
| Recall numbers | B-1846-13, B-1847-13 |
| Recalling firm | TissueTech, Inc. dba Bio-Tissue, Inc. |
| Product type | Biologics |
| Products | Amniotic membrane |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Amniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. |
| Initiation date | Mar 18, 2013 |
| Report date | May 29, 2013 |
| Termination date | Jun 13, 2013 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3003415347 |
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: