Device Recall Adler Instrument Company

  • Model / Serial
    1) Instrumed Item No.: 250-08800; Adler Instrument Company Catalog Code: 70-0300; Lot Number: 070113;  2) Instrumed Item No.: 250-08860 ; Adler Instrument Company Catalog Code: 70-0319; Lot Number: 030312, 070411;  3) Instrumed Item No.: 250-08930; Adler Instrument Company Catalog Code: 70-0318; Lot Number: 010113, 020113, 030112, 050412, 060413, 070512, 090213, 100113, 100411;  4) Instrumed Item No.: 250-08960 ; Adler Instrument Company Catalog Code: AD98-1008; Lot Number: 090310;  5) Instrumed Item No.: 250-09010 ; Adler Instrument Company Catalog Code: 70-0317; Lot Number: 100211
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • Product Description
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. || The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Instrumed International, Inc., 626 Cooper Ct, Schaumburg IL 60173-4537
  • Manufacturer Parent Company (2017)
  • Source
    USFDA