Device Recall Monoject Prefill 100UlmL Heparin

  • Model / Serial
    Lot Numbers: 7041194; 7102804; 7041204; 7113034; 7051534; 7113044; 7051544; 7113054; 7051554 ; 7113104; 7071924 ; 7113114; 7072034; 7113154; 7072044;  8010064; 7072054; 8010114; 7072064 ; 8010134; 7072154;  8010174; 7082284;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Tyco Healthcare Monoject Prefill100U/mL Heparin || Lock Flush Syringe 5mL || REF # 8881590125, Tyco Healthcare, Mansfield, MA 02048
  • 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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number:  7082284
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Tyco Healthcare Monoject Prefill 100UlmL Heparin || Lock Flush Syringe 5mL, with || BLUNTIP plastic cannula || REF # 8881591125, Tyco Healthcare, Mansfield, MA 02048
  • Manufacturer