Events

Rappel de HARVEST TERUMOBCT, GCP10 Graft Delivery Pack

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Terumo BCT, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    78309
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0075-2018
  • Date de mise en oeuvre de l'événement
    2017-10-20
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159146
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Syringe, piston - Product Code FMF
  • Cause
    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
  • Modèle / numéro de série
    UDI Case 35020583514493, Each 05020583514492  Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Terumo BCT, Inc., 10811 W Collins Ave, Lakewood CO 80215-4440
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA