HARVEST TERUMOBCT — Class II medical device recall Z-0075-2018
Terminated recall by Terumo BCT, Inc., reported 2017-11-15, distributed nationwide. Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inne
| Recall number | Z-0075-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo BCT, Inc., Lakewood, CO, United States |
| Recall initiated | 2017-10-20 |
| Classified | 2017-11-08 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2021-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 525 kits |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 05020583514492, 35020583514493 |
| Lot numbers | 04A9925, 05A9928, 06A9948, 06A9978, 08A9950 |
| Model numbers | 51449 |
| Expiration dates | 2018-03-01, 2019-05-01, 2019-06-01, 2019-08-01 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0075-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.