Events

Recall of HARVEST TERUMOBCT, GCP10 Graft Delivery Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo BCT, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78309
  • Event Risk Class
    Class 2
  • Event Number
    Z-0075-2018
  • Event Initiated Date
    2017-10-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159146
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Syringe, piston - Product Code FMF
  • Reason
    Certain lots of the harvest graft delivery system gdp-10 procedure packs may have a lack of a seal on the inner pouch.
  • Action
    Harvest Terumo sent a Voluntary Medical Device Product Recall letter dated October 20, 2017, to all affected customers. The letter stated the following: "ACTIONS REQUIRED FOR HEALTHCARE PROVIDERS AND DISTRIBUTORS 1. For product shelved in the original case (white box), or kit components, examine the outer label for catalog/lot numbers as shown in Figure A above. 2. Please return any unused affected product in your inventory. Please contact your local Terumo BCT Customer Support Center at 1.877.3.FYI.BCT (U.S. toll-free 1.877.339.4228) or +1.303.231.HELP (+1.303.231.4357), Terumo BCT Europe N.V. at +32.2.715.0590 or your local Terumo BCT representative, and Terumo BCT will issue a return goods authorization for product return. 3. Continue to use unaffected Harvest Graft Delivery System GDP-10 Procedure Packs in accordance with the instructions for use. 4. Distribute this notification to all Harvest Graft Delivery System GDP-10 Procedure Pack users within your organization. 5. IMPORTANT: Complete the attached acknowledgement form and return it by fax or email to Harvest Terumo BCT by 15 November 2017. Your return of the acknowledgement form is critical so we can confirm that you have received the recall notice. 6. As a reminder, please comply with the recommended practices for maintaining a sterile field as recommended by the Association of periOperative Registered Nurses (AORN) and refer to the instructions for use." Customers with questions, please contact your Terumo BCT representative or your regional Customer Support Center: ¿ U.S. Toll-Free: 1.877.3.FYI BCT (394 228) ¿ U.S.: +1.303.231.HELP (4357) ¿ Canada Toll-Free: 1.877.722.8411 ¿ Europe: +32.2.715.0590

Device

HARVEST TERUMOBCT, GCP10 Graft Delivery Pack
  • Model / Serial
    UDI Case 35020583514493, Each 05020583514492  Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.
  • 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
  • Manufacturer
    Terumo BCT, Inc.

Manufacturer

Terumo BCT, Inc.
  • Manufacturer Address
    Terumo BCT, Inc., 10811 W Collins Ave, Lakewood CO 80215-4440
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA