Events

Recall of Device Recall BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care Holdings, 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
    68585
  • Event Risk Class
    Class 2
  • Event Number
    Z-2632-2014
  • Event Initiated Date
    2014-06-23
  • Event Date Posted
    2014-09-12
  • 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=128271
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Reason
    Products were held at improper storage temperature.
  • Action
    Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate or BD Collection Tubes. If customers have the affected product, they will be instructed to contact FMC-RTG Customer Service to have the product replaced. On July 10, 2014 Fresenius issued a clarification letter to users to state only products from the identified lots that were delivered by RTG LLC to the specified facilities on May 5, 2014 are affected by this recall as the products were exposure to higher temperatures than recommended. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.

Device

Device Recall BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML)
  • Model / Serial
    Lot: 4007096
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of LA, OK, and TX.
  • Product Description
    BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) || Part Number: 363083 || Part Number: FMC 87-8380-1 || Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. || Trace elements, aluminum and zinc determination.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Manufacturer Address
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA