Events

Rappel de HARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure 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
    78307
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0104-2018
  • 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=159144
  • 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
    Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • Cause
    The patient labels included in the bmac system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. the expiration noted was not beyond initiation date of the recall. since the product is noted as sterile, the clearance for k103340, k052925 and k991430 raises question if product was cleared with a sterility claim. further post-market follow-up will be required to assess the safety risk of the product.
  • Action
    The firm initiated their recall by letter on 10/20/2017. The letter stated the following: "ACTIONS REQUIRED FOR HEALTHCARE PROVIDERS AND DISTRIBUTORS 1. For product shelved in the original procedure pack (white box), examine the label for catalog/lot numbers as shown in Figure C above. 2. If affected product is in your inventory, contact the 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 your unaffected product in accordance with the instructions for use. 4. Distribute this notification to all Harvest Bone Marrow Aspirate Concentrate (BMAC) System users within your organization. 5. IMPORTANT: Complete the attached acknowledgement and return it by fax or email to Terumo BCT by 27 October 2017. Your return of the acknowledgement is critical so we can confirm that you have received the recall notice.

Device

HARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure Pack
  • Modèle / numéro de série
    UDI Case: 35020583514233, 51423 Each: 05020583514232, Lot 04A9939
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
  • Description du dispositif
    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
  • 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