Device Recall Covidien

  • Model / Serial
    Lot Codes: 511752564X 516054164X 520853264X 525450264X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover P400 UM 18FR SIL COUDE SECURE || Item Code: P4P18CSDK || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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

76 devices with a similar name

Learn more about the data here

  • Model / Serial
    All lot numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. || Product Code: DUET6048A. || Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
  • Manufacturer
  • Model / Serial
    Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
  • Product Description
    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm || Product Code: 030450 || Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
  • Manufacturer
  • Model / Serial
    Model # 10007101; Lot # 14A0041IN
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
  • Product Description
    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. || The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
  • Manufacturer
  • Model / Serial
    Model # 10116080 ; Lot # PO643063
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
  • Product Description
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. || The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
  • Manufacturer
  • Model / Serial
    Model BVT608010, Lot numbers: 9853174, 9864497, 9890772, 9890931, 9925676, 9932672, 9937308, 9937315, 9940474, 9940614, 9976340, 9978233, A001589, A001740.   Model BVT608030, Lot Numbers: 9853331, 9887597, 9887695, 9887757, 9932042.   Model BVT612010, Lot numbers: 9854121, 9868214, 9868311, 9875472, 9875632, 9876174, 9883295, 9884788, 9884951, 9886196, 9886312, 9932096, 9968511, 9974109, 9974126, 9976472, 9977091, 9978862, A002299, A002423.   Model BVT312030, Lot numbers: 9854124, 9892081, 9941213, 9971096, 9971139, 9976506, 9977140, 9978964, 9979548, A003021, A003121, A003651, A007900, A008492, A008603, A008687.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries Australia, Canada, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. || Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
  • Manufacturer
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