Events

Recall of HARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure 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
    78307
  • Event Risk Class
    Class 2
  • Event Number
    Z-0104-2018
  • 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=159144
  • 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
    Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • Reason
    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
  • Model / Serial
    UDI Case: 35020583514233, 51423 Each: 05020583514232, Lot 04A9939
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
  • Product Description
    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
  • 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