# FDA recall Z-0075-2018

> **Terumo BCT, Inc.** · Class II · device recall initiated 2017-10-20.

## 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.

## Distribution

Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.

## Key facts

- **Recall number:** Z-0075-2018
- **Recalling firm:** Terumo BCT, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-20
- **Report date:** 2017-11-15
- **Termination date:** 2021-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lakewood, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0075-2018

## Citation

> AI Analytics. FDA recall Z-0075-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0075-2018. Source: US FDA. Licensed CC0.

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