Device Recall MONOJECT Prefill Heparin Lock Flush Syringe

  • Model / Serial
    Lot # 9081974, 9081984, 9082034, 9082074, 9082084
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    MONOJECT Prefill Heparin Lock Flush Syringe || 10 Unit Heparin, 5 ml in 12 ml syringe || Item code 8881580125
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Covidien LP, 15 Hampshire St, Mansfield MA 02048-1113
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot # 9081964
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    MONOJECT Prefill Heparin Lock Flush Syringe || 10 Unit Heparin, 10 ml in 12 ml syringe || Item code 8881580121
  • Manufacturer
  • Model / Serial
    Lot # 90181964
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    MONOJECT Prefill Heparin Lock Flush Syringe || 10 Unit Heparin, 3 ml in 12 ml syringe || Item code 8881580123
  • Manufacturer
  • Model / Serial
    Lot # 9082094
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    MONOJECT Prefill Heparin Lock Flush Syringe || 100 Unit Heparin, 3 ml in 12 ml syringe || Item code 8881590123
  • Manufacturer
  • Model / Serial
    Lot # 9082104, 9082114, 9082154, 9092164
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    MONOJECT Prefill Heparin Lock Flush Syringe || 100 Unit Heparin, 5 ml in 12 ml syringe || Item code 8881590125
  • Manufacturer