Class II — Terumo BCT, Inc.
| Recalling firm | Terumo BCT, INC. |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch. |
| Product | 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 Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary |
| Quantity | 525 kits |
| Distribution | Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT. |
| Initiated | 2017-10-20 |
| Classified | 2017-11-08 |
| Terminated | 2021-03-26 |
| Recall number | Z-0075-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Terumo BCT, Inc. (Z-0075-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78309/
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