Events

Recall of Reprocessed Microline Scissor Tips, Model s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by STERILMED, INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73871
  • Event Risk Class
    Class 2
  • Event Number
    Z-1846-2016
  • Event Initiated Date
    2016-04-26
  • Event Date Posted
    2016-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145714
  • Notes / Alerts
    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.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed - Product Code NUJ
  • Reason
    Sterlilmed is recalling all unexpired scissor tips because of a potential manufacturing defect that can possibly result in a patient injury.
  • Action
    Consignees were sent on /26/2016 a Sterilmed "Urgent Medical Device Recall" letter dated April 26, 2016. The letter was addressed to either Materials Manager, Risk Manager and Operating Room Director or Distributor. The letter described the problem, the product involved in the recall and the actions required. Advised consignees to immediately quarantine and return the affected product and to complete and return the "Business Reply Form" to Sterilcycle. Advised Distributors to forward the letter to their customers if product was sent to them. For questions contact Sterilmed's Customer Care Team at 1-888-541-0078 .

Device

Reprocessed Microline Scissor Tips, Model s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162
  • Model / Serial
    Lot Number MIC3112 / 1850033 1851382 1852899 1853678 1855660 1856511 1856900 1859438 1859965 1860367 1861563 1862954 1863647 1864260 1865162 1865993 1867015 1867706 1868934 1870036 1870103 1871206 1872270 1873830 1874518 1875721 1876911 1878327 1879082 1880420 1880667 1880964 1882288 1883924 1884996 1886199 1886912 1887725 1889721 1889771 1890036 1890089 1891061 1891534 1891745 1892678 1893796 1893818 1893872 1894880 1895807 1896467 1897219 1898693 1899180 1900106 1901160 1901950 1903029 1903645 1904549 1905627 1906345 1907168 1907920 1908583 1909201 1910229 1911281 1912196 1912496 1913274 1913316 1914703  MIC3122/ 1850033 1851382 1856511 1856900 1859438 1861563 1868934 1870103 1872882 1875721 1878327 1879082 1896467 1897219 1898693 1899795 1900106 1901160 1903029 1905604 1906345 1907168 1910229 1911281 1912196  MIC3132 / 1850033 1851382 1852883 1852899 1853678 1854157 1856900 1859965 1860367 1861563 1862954 1863647 1864094 1864260 1865993 1867706 1868934 1870036 1870103 1871206 1872882 1874798 1874852 1875721 1878327 1879082 1879555 1880420 1880964 1883924 1884996 1886199 1886912 1887725 1889721 1891061 1891534 1891745 1892678 1899180 1899795 1900106 1901160 1905627 1909201 1910229 1910810 1911873 1912496 1913520  MIC3142 / 1850033 1851382 1852859 1852883 1852899 1852905 1853937 1854157 1855660 1855815 1856511 1856900 1859438 1859745 1859965 1860193 1860367 1861563 1862228 1862954 1863647 1864260 1865162 1865902 1867015 1867706 1868934 1869589 1870103 1871206 1872270 1872882 1873830 1874518 1874798 1875721 1876911 1878327 1879082 1880420 1880667 1880964 1881991 1882288 1883924 1884996 1886199 1886912 1887725 1889044 1889486 1889720 1889721 1889771 1890036 1890089 1891060 1891061 1891745 1892678 1893536 1893796 1893872 1894880 1895806 1895807 1896467 1897219 1898693 1899180 1900106 1900854 1901160 1901950 1903029 1903645 1904549 1905604 1906345 1907009 1907168 1907920 1908583 1909201 1910229 1910810 1911135 1911281 1911873 1912136 1912156 1912184 1912196 1912496 1913221 1913255 1913274 1913316 1913520 1914703  MIC3152 / 1850033 1851382 1852899 1854157 1855660 1856511 1859438 1859965 1860367 1861563 1862954 1863647 1864260 1867015 1867706 1868934 1869589 1870103 1871206 1872270 1872882 1873830 1874852 1875721 1876911 1878327 1879082 1880667 1880964 1882288 1883924 1884996 1886912 1887725 1889044 1889721 1889771 1890036 1890089 1891060 1891061 1891745 1892678 1893796 1893818 1893872 1895806 1895807 1896467 1897219 1898693 1899180 1900106 1901160 1901950 1903029 1903645 1907168 1907920 1908583 1909201 1910229 1910810 1911281 1911873 1912196 1912496 1913221 1913274 1913316 1913520 1914703
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: AL, AR, CA, CO, FL, GA, IN,IA, KY, MD, MA, MI, MN, MO, NV, NJ, NC, OH, OK, OR, PA,, SC, TN, TX, VA, WA, WV, WI. Canada
  • Product Description
    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
  • Manufacturer
    STERILMED, INC.

Manufacturer

STERILMED, INC.
  • Manufacturer Address
    STERILMED, INC., 11400 73rd Ave N, Maple Grove MN 55369-5561
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA