Events

Rappel de Device Recall BD Vacutainer EDTA Tubes

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 Becton Dickinson & Company.

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
    79223
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1139-2018
  • Date de mise en oeuvre de l'événement
    2018-03-22
  • Date de publication de l'événement
    2018-03-22
  • 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=161677
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA