Recall Z-0075-2018— Terumo BCT, Inc.

Name: FDA recall Z-0075-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-20

Class II · Terminated

Class II FDA medical device recall by Terumo BCT, Inc., initiated 2017-10-20, terminated 2021-03-26. It names one FDA 510(k) clearance: K043261. 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: Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch..

Recalling firm: Terumo BCT, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-20
Terminated: 2021-03-26
Firm location: Lakewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K043261 — HARVEST GRAFT DELIVERY SYRINGEHarvest Technologies, Corp.·cleared 2005-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.