Home / Recalls / Terumo BCT, Inc. / Z-0075-2018

Z-0075-2018 Class II Terminated

Recalled by Terumo BCT, Inc. — Lakewood, CO

Recall Details

Product Type: Devices
Report Date: November 15, 2017
Initiation Date: October 20, 2017
Termination Date: March 26, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 525 kits

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.

Distribution Pattern

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

Code Information

UDI Case 35020583514493, Each 05020583514492 Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019