Drug recall
Human Tendon
FDA recall event 80332 · Class II · AlloSource, Inc.
Key facts
| Event ID | 80332 |
|---|---|
| Recall numbers | B-0658-2018 |
| Recalling firm | AlloSource, Inc. |
| Product type | Biologics |
| Products | Human Tendon |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue allografts, where in process controls were not followed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or… |
| Initiation date | Jun 22, 2017 |
| Report date | Jul 11, 2018 |
| Termination date | Jun 29, 2018 |
| City | Centennial |
| State | CO |
| Country | United States |
| FEI number | 3000215346 |
At a glance
- 1–9 Products in this recall
- 10–99 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: