Device Recall MONOJECT Prefill Heparin Lock Flush Syringe

Fabricante

  • Dirección del fabricante
    Covidien LP, 15 Hampshire St, Mansfield MA 02048-1113
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot # 90181964
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda
  • Descripción del producto
    MONOJECT Prefill Heparin Lock Flush Syringe || 10 Unit Heparin, 3 ml in 12 ml syringe || Item code 8881580123
  • Manufacturer
  • Modelo / Serial
    Lot # 9081974, 9081984, 9082034, 9082074, 9082084
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda
  • Descripción del producto
    MONOJECT Prefill Heparin Lock Flush Syringe || 10 Unit Heparin, 5 ml in 12 ml syringe || Item code 8881580125
  • Manufacturer
  • Modelo / Serial
    Lot # 9082094
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda
  • Descripción del producto
    MONOJECT Prefill Heparin Lock Flush Syringe || 100 Unit Heparin, 3 ml in 12 ml syringe || Item code 8881590123
  • Manufacturer
  • Modelo / Serial
    Lot # 9082104, 9082114, 9082154, 9092164
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda
  • Descripción del producto
    MONOJECT Prefill Heparin Lock Flush Syringe || 100 Unit Heparin, 5 ml in 12 ml syringe || Item code 8881590125
  • Manufacturer