Drug recall
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is…
FDA recall event 78309 · Class II · Terumo BCT, Inc.
Key facts
| Event ID | 78309 |
|---|---|
| Recall numbers | Z-0075-2018 |
| Recalling firm | Terumo BCT, Inc. |
| Product type | Devices |
| Products | HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch. |
| Initiation date | Oct 20, 2017 |
| Report date | Nov 15, 2017 |
| Termination date | Mar 26, 2021 |
| City | Lakewood |
| State | CO |
| Country | United States |
| FEI number | 1000117351 |
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: