Drug recall
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
FDA recall event 86807 · Class II · TissueTech, Inc.
Key facts
| Event ID | 86807 |
|---|---|
| Recall numbers | Z-0550-2021, Z-0551-2021, Z-0552-2021 |
| Recalling firm | TissueTech, Inc. |
| Product type | Devices |
| Products | PROKERA, non-sterile - Product Usage: Biologic corneal bandage., PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage., PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential exposure of product to microbial contamination. |
| Initiation date | Nov 10, 2020 |
| Report date | Dec 16, 2020 |
| Termination date | Jul 6, 2023 |
| City | Doral |
| State | FL |
| Country | United States |
| FEI number | 3009809074 |
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: