Events

Recall of Device Recall BD Vacutainer EDTA Tubes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

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
    79223
  • Event Risk Class
    Class 1
  • Event Number
    Z-1139-2018
  • Event Initiated Date
    2018-03-22
  • Event Date Posted
    2018-03-22
  • 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=161677
  • 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
    Bd vacutainer edta lavender, tan, and pink top tubes and bd vacutainer lithium heparin green top tubes can cause an underestimation of lead in blood samples when used with magellan diagnostics leadcare assays, employing the anodic stripping voltammetry (asv) methodology, or any other assay employing asv methodology.
  • Action
    On March 22, 2018, BD issued a press release. BD intends to distribute URGENT MEDICAL DEVICE CORRECTION notices to their customers in the upcoming days via courier service. The URGENT MEDICAL DEVICE CORRECTION notification has been posted on BD's website along with a link to their press release. BD has updated the IFU for BD Vacutainer EDTA and BD Vacutainer Lithium Heparin Tubes to include the noted precaution for use of Lavender, Tan, Pink and Green Top tubes on Magellan Diagnostics Leadcare assays using ASV methodology. **Distributors are advised to Take the Following Actions: 1) This is a Medical Device Correction and there is no need to return or discard product. The product can continue to be used with other non-ASV blood lead level test technologies such as GFAAS and ICP-MS and all assays which do not employ ASV methodology. 2) If you have distributed this product, please identify your customers and notify them of this recall by sharing a copy of the correction notice. 3) Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the covered product. 4) If you would like BD to conduct the notification to your customers, please email your customer list within 3 business days to BDPASRC@bd.com. Please include the contact name, address, phone number, email address, and/or fax numbers for each customer. Distributors who require further assistance, please contact BD at 1-888-237-2762 (select Option #3 and then Option # 4) between 8AM and 5 PM, CT Monday through Friday. **Medical Directors, Risk Managers, Medical Device Safety Officers & Lab Managers are advised to Take the Following Actions: 1) This is a Medical Device Correction and there is no need to return or discard product. The product can continue to be used with other non-ASV blood lead level test technologies such as GFAAS and ICP-MS and all assays which do not employ ASV methodology. 2) Continue to follow FDA's safety

Device

Device Recall BD Vacutainer EDTA Tubes
  • Model / Serial
    All lots. Catalog Number (Shelf Life): 1. 366401 (24 months); 2. 366450 (24 months); 3. 366643 (12 months); 4. 367835 (16 months); 5. 367841 (15 months); 6. 367844 (16 months); 7. 367856 (16 months); 8. 367861 (16 months); 9. 367862 (16 months); 10. 367863 (17 months); 11. 368021 (16 months); 12. 368047 (15 months); 13. 368054 (16 months); 14. 368661 (17 months); 15. 364300 (Requested)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in 46 states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Puerto Rico.
  • Product Description
    BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 50382903678568); 8. 367861 (UDI: 50382903678612); 9. 367862 (UDI: 50382903678629); 10. 367863 (UDI: 50382903678636); 11. 368021 (UDI: 50382903680219); 12. 368047 (UDI: 50382903680479); 13. 368054 (UDI: 50382903680547); 14. 368661 (UDI: 50382903686617); 15. 364300 (UDI: pre-UDI)
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA