FDA recall Z-0075-2018

Terumo BCT, Inc. · Class II · device

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

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

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